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associate director gvp gcp quality assurance auditor

Organon Pharmaceuticals

<div>The Position
The Associate Director, GVP/GCP Quality Assurance Auditor, is responsible for ensuring quality and compliance with local and international regulatory requirements by conducting audits of Organon Processes, Affiliates, Vendors, Business Partners, and Investigator sites. The Associate Director is responsible for accepting audit assignments, performing audit pre-work, conducting audits and ensuring post audit activities are completed within defined timeframes. This role provides guidance to internal stakeholders, assisting in the establishment of the company's compliance strategy and the resolution and prevention of compliance risks.
Responsibilities<ul><li>
Schedule and conduct assigned GVP/GCP audits in accordance with the global audit plan ensuring compliance with local and international guidelines and regulations.</li><li>
Prepare audit reports and manage follow-up activities within established timelines.</li><li>
Maintain broad-based expertise in Organon Policies, Procedures and Guidelines, local and global regulatory requirements, etc., pertinent to GCP and GVP. Maintain awareness of evolving industry and regulatory trends/regulations.</li><li>
Obtain and maintain cutting-edge knowledge, and application, for various Quality auditing topics.</li><li>
Generate and present comprehensive presentations/summary of audit issues for effective communication to all levels, as needed.</li><li>
Leads initiatives / drive results in various projects, as assigned, to maintain the effectiveness and efficiency of the audit program, and to ensure the audit program continues to meet company and regulatory expectations.</li><li>
Supports the implementation and maintenance of the GVP/GCP risk-based strategy, including assistance in the development of the annual audit plan and maintenance of the audit tool.</li><li>
Reviews and provides input into the quality sections of the Pharmacovigilance System Master File (PSMF)</li><li>
Supports regulatory inspections and external audits, when required.</li><li>
Train and mentor junior team members.</li></ul>
Required Education, Experience, and Skills
<ul><li>A minimum of a Bachelor&rsquo;s degree in a relevant scientific field (Pharmacy, Life Sciences, etc.).</li><li>
Fluency in written and spoken English; additional language skills a plus.</li><li>
Minimum of ten (10) years of experience in the pharmaceutical industry or regulatory agency related to Quality Systems and Quality Assurance (e.g., clinical trial quality, pharmacovigilance, regulatory)</li><li>
Minimum of one (1) years of experience in GVP and/or GCP auditing with EU/FDA /global regulatory requirements</li><li>
Strong knowledge of EMA, FDA and ICH guidelines in GCP and GVP and proficiency in interpreting and applying regulatory requirements and guidelines</li><li>
Attention to detail and ability to work independently in a virtual environment</li><li>
Proficiency in Microsoft applications (Word, Excel, PowerPoint, Outlook)</li><li>
Excellent/accomplished communication, negotiation, facilitation, influencing, and strategic thinking skills at all levels of organization Availability to travel up to 20% of time.</li></ul>
Primary skills include but are not limited to:
Collaboration and Partnering: Demonstrates ability to work in partnership with others within the Company and external partners to accomplish quality goals; possesses advanced leadership skills.
Communication Skills: Strong verbal skills and experienced effective writing skills.
Project Management: Demonstrates ability to organize work efforts, prioritization of tasks and utilize appropriate resources to deliver or support work products in accordance with timelines and appropriate regulations.
Decision Making: Demonstrates skills to utilize knowledge, networks, and data to make rapid and appropriate decisions and to determine when escalation of issues is necessary.
Business Operations/Knowledge of Field: Demonstrates knowledge of regulations. Regulatory and business trends and applies this knowledge to optimize daily activities and ensure the functional areas within Research and Development are compliant with regulations and appropriate procedures.
Secondary Job Description
Who We Are:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women&rsquo;s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.
Search Firm Representatives Please Read Carefully 
Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Annualized Salary Range
Annualized Salary Range (Global)
Annualized Salary Range (Canada)
Please Note: Pay ranges are specific to local market and therefore vary from country to country.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1 
Requisition ID:R537874</div>

Associate Director, GVP/GCP Quality Assurance Auditor

Parexel

<div>Key Accountabilities:<div><div><div><div><div><div><div><div><div>
Site Management Responsibilities<ul><li>
Contributes to the selection of potential investigators.
</li><li>In some countries, as required, Sr CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
</li><li>Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.
</li><li>Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are always inspection ready.
</li><li>Actively participates in Local Study Team (LST) meetings.
</li><li>Contributes to National Investigators meetings, as applicable.</li><li>
Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST.
</li><li>Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.
</li><li>Updates CTMS and other systems with data from study sites as per required timelines.
</li><li>Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.</li><li>
Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSAD the correct timing and type of visits.
</li><li>Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.
</li><li>Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.
</li><li>Ensures data query resolution in a timely manner.
</li><li>Works with data management to ensure robust quality of the collected study data.
</li><li>Ensures accurate and timely reporting of Serious Adverse Events and their follow ups.</li><li>
Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP.
</li><li>Follows up on outstanding actions with study sites to ensure resolution in a timely manner.
</li><li>Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required.
</li><li>Assists site in maintaining inspection ready ISF.
</li><li>Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD).
</li><li>Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate.
 </li><li>Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF.
</li><li>Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
</li><li>Collaborates with local Medical Scientific Liaisons (MSLs) as directed by LSAD or line manager</li></ul>
Compliance with Sponsor Standards<ul><li>
Ensures compliance with the Client&rsquo;s Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment).</li><li>
Ensures compliance with local, national, and regional legislation, as applicable.
</li><li>Completes timesheets accurately as required</li></ul>
Compliance with Parexel Standards<ul><li>
Complies with required training curriculum.
</li><li>Completes timesheets accurately as required.
</li><li>Submits expense reports as required.
</li><li>Updates CV as required.
</li><li>Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements.</li></ul>
Skills (Essential):
<ul><li>Excellent attention to detail.
</li><li>Good written and verbal communication skills.
</li><li>Good collaboration and interpersonal skills.
</li><li>Good negotiation skills.
</li><li>Proficient in written and spoken English language required.
</li><li>Fluency in local language(s) required.
</li></ul>Skills (Desirable):
<ul><li>Ability to work in an environment of remote collaborators. Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.
</li><li>Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
</li><li>Good analytical and problem-solving skills.
</li><li>Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
</li><li>Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.
</li><li>Team oriented and flexible; ability to respond quickly to shifting demands and opportunities Knowledge and Experience (Essential):
</li><li>Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. &bull; Good knowledge of relevant local regulations.
</li><li>Good medical knowledge and ability to learn relevant Client Therapeutic Areas.
</li><li>Basic understanding of the drug development process.
</li><li>Good understanding of Clinical Study Management including monitoring, study drug handling and data management.</li></ul>
Knowledge and Experience (Desirable):
<ul><li>Familiar with risk-based monitoring approach including remote monitoring.
</li><li>Good cultural awareness.
</li></ul>Education:
<ul><li>Bachelor&rsquo;s degree in related discipline, preferably in life science, (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.</li></ul>
Other:<ul><li>
Ability to travel nationally/internationally as required.
</li><li>Valid driving license per country requirements, as applicable</li></ul></div></div></div></div></div></div></div></div></div></div>

Senior Clinical Research Associate & CRAII - FSP (Open)

PwC Türkiye

<div>
 
 
 At PwC, our purpose is to build trust in society and solve important problems
 
 
 
 We&rsquo;re a network of firms in 151 countries with more than 360,000 people who are committed to delivering quality in assurance, advisory and tax services. PwC has been providing services to the Turkish business world since 1981, with a professional staff of 2.800 in &Idot;stanbul, Ankara, Bursa, &Idot;zmir and Eski&scedil;ehir.
 
 
 
 
 
 At PwC, we are a group of employees with a rich variety of knowledge, skills and competencies. PwC&rsquo;s problem-solving teams come together in unusual, untraditional new ways from various disciplines to create The New Equation strategy. The New Equation is our global strategy with a human-centered and tech-powered approach, that focuses on our clients and all stakeholders, and helps them build trust and drive sustainable results.
 
 
 
 
 
 As part of the continuous growth of our Risk Modelling practice and significantly increasing further market opportunities, PwC &ldquo;
 
 Risk Assurance &ndash; Risk Modelling&rdquo;
 
 ' team is looking for new
 
 Associate / Senior Associates
 
 to be a part of our expanding practice.
 
 
 
 
 
 As an Associate/Senior Associate in Risk Assurance Services at PwC, you will play a crucial role in assisting clients with identifying, managing, and mitigating risks related to their business operations. Working within our dynamic and collaborative team, you will contribute to delivering high-quality risk management solutions that help clients maintain trust and confidence in their financial reporting, regulatory compliance, and overall business processes.
 
 
 
 
 
 
 
 Qualifications
 
 
 
 <ul>
 <li>
 Graduated from University&rsquo;s related Engineering, Economics, Statistics, Econometrics or Mathematics departments (Master&rsquo;s degree in business, finance or a quantitative field is preferred)
 </li>
 <li>
 Minimum of 2 years of experience in Financial Risk Management and machine learning models is a plus
 </li>
 <li>
 Prior experience in financial risk management with a focus of credit risk is a plus
 </li>
 <li>
 Strong analytical and statistical skills with the ability to think critically and solve complex problems.
 </li>
 <li>
 Experience in IRB and/or IFRS9 concepts and modeling techniques is a plus
 </li>
 <li>
 Excellent communication skills, both written and verbal, to articulate findings and recommendations effectively.
 </li>
 <li>
 High attention to detail and a commitment to delivering accurate and reliable work.
 </li>
 <li>
 Proficiency in MS Excel
 </li>
 <li>
 Excellent writing and communications skills (in English)
 </li>
 <li>
 Project management experience is a plus
 </li>
 <li>
 Experience in working with large datasets is a plus
 </li>
 <li>
 Proficiency in SQL, SAS, Python,R is a plus (knowledge of at least two of these languages at an advanced level)
 </li>
 <li>
 Ability to work effectively in a team environment and collaborate with diverse groups of professionals.
 </li>
 </ul>
 
 
 
 
 
 
 Job Description
 
 
 
 
 The prospective candidates are expected to deliver risk management and measurement solutions to the financial and non-financial institutions through engagements and practice development. Prospective candidates are expected to:
 
 <ul>
 <li>
 Coordinate with clients to identify their risk management needs especially in the area of financial risks and risk modelling and develop strategies within these frameworks and gather information and understand client organization and processes
 </li>
 <li>
 Organize meetings and coordinate different project parties
 </li>
 <li>
 Analyze/map business processes in risk management, document and present business process and methodologies
 </li>
 <li>
 Contribute to the review and/or evaluation of risk measurement data and methodologies and risk management policies
 </li>
 <li>
 Contribute to the risk modeling process using statistical and econometric analysis techniques
 </li>
 <li>
 Execute appropriate analytic strategies
 </li>
 <li>
 Mine raw data sets to perform any analyses that are needed
 </li>
 <li>
 Liaison with other PwC line of services and with third party other advisors in the projects to maximize efficiency and ensure to deliver highest quality services
 </li>
 </ul>
 
 
 
 
 
 Key Responsibilities:
 
 
 <ul>
 <li>
 Utilize data analytics tools to analyze large datasets and identify patterns or anomalies that could indicate potential risks or control deficiencies.
 </li>
 <li>
 Develop and maintain positive working relationships with clients, actively listen to their concerns, and communicate effectively to address their needs.
 </li>
 <li>
 Work closely with other team members to deliver integrated solutions to clients, leveraging cross-functional expertise to provide comprehensive risk assurance services.
 </li>
 <li>
 Stay abreast of industry trends, emerging risks, and evolving best practices in risk management and assurance. Engage in continuous professional development to enhance skills and knowledge.
 </li>
 <li>
 Prepare clear and concise workpapers and reports, detailing the results of risk assessments, testing procedures, and recommendations for clients.
 </li>
 <li>
 Embrace innovative technologies and tools to optimize risk assurance processes and deliver value-added insights to clients.
 </li>
 </ul>
 
 
 
 
 --
 
 
 
 PwC T&uuml;rkiye &scedil;irketleri* olarak elektronik ortamda toplanan kimlik, ileti&scedil;im, &ouml;zge&ccedil;mi&scedil; ve CV&rsquo;niz&rsquo;de yer alan ki&scedil;isel verilerinizi i&scedil; ba&scedil;vurusu s&uuml;re&ccedil;lerinin y&uuml;r&uuml;t&uuml;lmesi amac&inodot;yla KVKK m. 5/2 (f) uyar&inodot;nca, hukuki ihtilaf olu&scedil;mas&inodot; halinde yasal s&uuml;re&ccedil;lerin y&uuml;r&uuml;t&uuml;lebilmesi amac&inodot;yla KVKK m. 5/2 (e) uyar&inodot;nca i&scedil;leyece&gbreve;iz. Ki&scedil;isel verilerinizi mevzuattan dolay&inodot; ki&scedil;isel verilerinizin payla&scedil;&inodot;lmas&inodot;n&inodot;n zorunlu oldu&gbreve;u hallerde, ilgili ve yetkili kamu kurum ve kurulu&scedil;lar&inodot;yla KVKK m. 5/2 (&ccedil;) uyar&inodot;nca payla&scedil;abiliriz. Ki&scedil;isel verilerinin KVKK m. 9 uyar&inodot;nca merkezi yurt d&inodot;&scedil;&inodot;nda bulunan Google sistemleri &uuml;zerinden i&scedil;lenecektir. KVKK&rsquo;n&inodot;n 11. Maddesi kapsam&inodot;ndaki haklar&inodot;n&inodot;z&inodot; https://www.pwc.com.tr/tr/hakkimizda/pwc-turkiye-kvk-basvuru-formu.pdf linkinde bulunan Ba&scedil;vuru Formu ile veya pwc.turkiye@hs03.kep.tr adresine, veya tr.dpo@tr.pwc.com adresine iletebilirsiniz.
 
 
 
 
 
 
 
 *PwC T&uuml;rkiye &scedil;irketleri; PwC Dan&inodot;&scedil;manl&inodot;k Hizmetleri A.&Scedil;. &amp; PwC Ba&gbreve;&inodot;ms&inodot;z Denetim ve Serbest Muhasebeci Mali M&uuml;&scedil;avirlik A.&Scedil;. &amp; PwC Yeminli Mali M&uuml;&scedil;avirlik A.&Scedil;. &amp; PwC Y&ouml;netim Dan&inodot;&scedil;manl&inodot;&gbreve;&inodot; A.&Scedil;., PwC Serbest Muhasebeci Mali M&uuml;&scedil;avirlik Ltd. &Scedil;ti., Gago T&uuml;rkmen Avukatl&inodot;k Ortakl&inodot;&gbreve;&inodot;
 
 
</div>

Risk Modelling - Associate/Senior Associate (JP00276)

Eli Lilly

<div>At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We&rsquo;re looking for people who are determined to make life better for people around the world.<h3 class="jobSectionHeader">
Overview</h3>
The Clinical Research Lead (CRL) is responsible for managing clinical investigators and sites participating in Lilly clinical trials and/or Post-Marketing Safety Studies. This includes investigator/site identification and qualification, ensuring timely trial enrollment aligned with scientific objectives, database lock delivery, issue resolution at trial sites, and maintaining inspection readiness at all times.
The CRL ensures global program delivery through comprehensive investigator and site management, leveraging data and tools for informed decisions, and fostering high-quality interactions with clinical trial sites to provide an unparalleled customer experience. Additionally, the CRL oversees vendor monitoring activities, identifying and mitigating significant findings and trends.
In countries without an Associate Director/Director of Investigator Engagement, the CRL may represent Investigator Engagement internally and externally, including interactions with regulatory bodies and influencing the local regulatory environment and strategy.<h3 class="jobSectionHeader">
Primary Responsibilities</h3>
Clinical Investigator Management<ul><li>
Manage all activities at clinical trial sites, including site identification, qualification, enrollment planning, execution, and close-out.</li><li>
Ensure timely delivery of enrollment readiness, trial recruitment, and database locks through performance management and issue resolution.</li><li>
Identify opportunities to accelerate trial enrollment while maintaining an exceptional customer experience.</li><li>
Apply scientific, therapeutic area, and regional expertise to support trial execution and quality data delivery.</li><li>
Develop strategic institutional/site relationships to optimize clinical trial programs across therapeutic areas.</li></ul>
Clinical Trial Management<ul><li>
Implement investigator/site risk plans to meet enrollment and database lock commitments.</li><li>
Maintain site and country-level inspection readiness at all times.</li><li>
Use metrics to inform site/country/regional decision-making.</li><li>
Collaborate with internal and external teams to remove barriers to trial execution.</li><li>
Understand local treatment paradigms and standard of care to support feasibility and trial allocation.</li><li>
Provide vendor oversight for site monitoring activities.</li><li>
For countries with PMS requirements: manage Post-Marketing Safety Studies, including CRO selection, regulatory documentation, and project management.</li></ul>
Business Management and Engagement<ul><li>
Build strong professional relationships with clinical investigators to expand research partnerships and deliver an exceptional trial experience.</li><li>
Collaborate cross-functionally to align priorities and deliver the portfolio.</li><li>
Prospect targeted sites in line with portfolio strategy.</li><li>
Maintain therapeutic and technical expertise for scientific discussions with investigators and site staff.</li><li>
Act as a communication bridge between sites, vendors, and Lilly.</li><li>
Influence internal and external factors to improve clinical research delivery.</li></ul>
Country/Regulatory Responsibilities (where applicable)<ul><li>
Engage with regulatory bodies, ethical review boards, and national authorities to represent Lilly in the clinical trial environment.</li><li>
Participate in country pharmaceutical associations and affiliated bodies.</li><li>
Ensure compliance with local regulatory requirements and maintain internal processes accordingly.</li><li>
Contribute to external clinical development community initiatives and incorporate learnings into internal strategies.</li><li>
Support affiliate leadership in implementing regional initiatives.</li></ul><h3 class="jobSectionHeader">
Minimum Qualifications</h3><ul><li>
Bachelor&rsquo;s degree or equivalent (preferably in a scientific or health-related field).</li><li>
Minimum 3 years of experience in pharmaceutical industry and/or clinical research.</li><li>
Strong knowledge of Good Clinical Practice (GCP).</li><li>
Ability to acquire and maintain therapeutic expertise to support portfolio needs.</li><li>
Excellent organizational and self-management skills.</li><li>
Strong communication skills (verbal and written) and ability to influence others.</li><li>
Strategic agility and broad business acumen.</li><li>
Demonstrated leadership behaviors and ability to lead in uncertain environments.</li></ul><h3 class="jobSectionHeader">
Additional Preferences</h3><ul><li>
Strong organizational and planning skills.</li><li>
Ability to enhance customer experience.</li><li>
Fluent in English.</li><li>
Knowledge of country regulatory guidelines.</li><li>
Strong teamwork and interpersonal skills.</li><li>
Ability to develop innovative solutions.</li><li>
Travel required (50&ndash;75%).</li></ul>
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
#WeAreLilly</div>

Clinical Research Lead

Amgen

<div>Join Amgen&rsquo;s Mission of Serving Patients
At Amgen, if you feel like you&rsquo;re part of something bigger, it&rsquo;s because you are. Our shared mission&mdash;to serve patients living with serious illnesses&mdash;drives all that we do.
Since 1980, we&rsquo;ve helped pioneer the world of biotech in our fight against the world&rsquo;s toughest diseases. With our focus on four therapeutic areas &ndash;Oncology, Inflammation, General Medicine, and Rare Disease&ndash; we reach millions of patients each year. As a member of the Amgen team, you&rsquo;ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you&rsquo;ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Live
What you will do
Let&rsquo;s do this! Let&rsquo;s change the world! The role provides proactive end to end quality support for the development and implementation of a risk-based quality assurance strategy for the clinical development program.
The role will support end to end quality oversight of the General Medicine &amp; Obesity Therapeutic Area and will be responsible for supporting a risk-based quality strategy that advances quality by design principles for the full clinical trial lifecycle (protocol development, database lock, and regulatory submissions/ approvals).
You will play a vital role by developing deep knowledge of the clinical trials you support and provide oversight and quality management of critical data and processes for global and local study teams and all clinical trial sites who participate in Amgen sponsored trials.
Responsibilities<ul><li>
Act as a Good Clinical Practice (GCP) Subject Matter Expert, offering independent, objective quality guidance.</li><li>
Oversee quality across all clinical development stages.</li><li>
Plan and execute risk-based GCP audits (sites, affiliates, vendors, studies).</li><li>
Support regulatory inspections and guide responses, including root cause analysis and CAPAs.</li><li>
Lead quality oversight of Risk Assessment Categorization Tools (RACT) for each trial.</li><li>
Facilitate monthly quality risk reviews with clinical program leaders.</li><li>
Manage audit findings, deviations, and CAPA responses.</li><li>
Ensure regional compliance with local regulations and support vendor evaluations.</li><li>
Analyze data quality trends, identify gaps, and implement corrective actions.</li><li>
Oversee technologies for endpoint data collection (e.g., biomarkers, imaging).</li><li>
Develop and execute TA-specific QA plans and protocol-specific audit strategies.</li><li>
Support quality management activities including deviations, breaches, and inspection readiness.</li><li>
Drive innovation in quality oversight using data analytics, AI, and NLP.</li><li>
Review protocols to simplify design and identify critical data/processes.</li></ul>
Country/ Regional Quality Leadership<ul><li>
Manage analytical tools and data trends to address site/regional quality gaps.</li><li>
Provide oversight for key sites in collaboration with regional operations.</li><li>
Conduct Quality Partnership Visit at key sites within the country/Region</li><li>
Share best practices and compliance insights with stakeholders.</li><li>
Offer independent quality consultation and escalate issues as needed.</li><li>
Support local vendor assessments and pre-inspection activities.</li><li>
Conduct regional risk assessments for audit planning.</li><li>
Stay current on regulatory trends and deliver ongoing training.</li></ul>
Win
WHAT WE EXPECT OF YOU
We are all different, yet we all use our unique contributions to serve patients. The individual we seek has technological literacy and leadership skills, and has these qualifications:
Doctorate degree and 2 years of Quality Management, Quality Assurance and Good Clinical Practices experience in the pharmaceutical/biotech industry where risk-based quality management and quality by design are a core responsibility.
Or
Master&rsquo;s degree and 4 years of the previous mentioned experience
Or
Bachelor&rsquo;s degree and 6 years of the previous mentioned experience
Or
Associate&rsquo;s degree and 10 years of the previous mentioned experience<ul><li>
Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise.</li><li>
Thorough understanding of Clinical R&amp;D activities and Global Regulations.</li><li>
Experience with Regulatory Submission and Inspection Management procedures.</li><li>
Quality Oversight of Clinical Trials, including clinical trial protocol development, execution, and submissions.</li><li>
Leadership or mentoring experience is ideal, in a regional capacity would be phenomenal.</li><li>
Excellent verbal and written communication skills, including strong business writing abilities and active listening. Able to understand and articulate technical concepts and literature in spoken and written English.</li><li>
Ability to transform business and stakeholder feedback into clear, efficient processes using a straightforward language and format.</li><li>
Self-driven with strong analytical, critical-thinking, prioritization, and decision-making abilities.</li></ul><h2 class="jobSectionHeader">
IMPORTANT! Please submit your resume/CV in English!</h2><h2 class="jobSectionHeader">
Thrive</h2>
WHAT YOU CAN EXPECT OF US<ul><li>
Vast opportunities to learn, develop, and move up and across our global organization.</li><li>
Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act.</li><li>
Generous Amgen Total Rewards Plan comprising healthcare, finance, wealth and career benefits.</li><li>
Flexible work arrangements.</li></ul><h2 class="jobSectionHeader">
Apply now</h2>
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us: Careers.amgen.com
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.</div>

Quality Compliance Senior Manager

Arup

<div></div><div><div><div><div><div><div>Energy
 </div></div></div><div></div><div>Europe Region
 </div><div></div><div>IST000013</div></div><div><div> 
</div></div></div><div>Shape a future with purpose at Arup in Istanbul &amp; Ankara.
Arup&rsquo;s purpose, shared values and collaborative approach has set us apart for over 75 years, guiding how we shape a better world.
The Opportunity
Play a key role in shaping sustainable and energy-efficient solutions by joining our Sustainability Team as an Industrial Energy Auditor! Your expertise will directly influence the transition to greener buildings and corporate sustainability practices, making a tangible difference in combating climate change.
Drive innovation in energy efficiency and collaborate on impactful policies at city and national levels.
As an Industrial Energy Auditor at Arup, you will:<ul><li>
Work closely with multidisciplinary design teams to help building designs to be energy efficient at the concept design stage.</li><li>
Develop sustainability policies and capacity assessments for municipalities and ministries,</li><li>
Able to audit mechanical and electrical equipment in commercial and industrial facilities, develop ECM's (energy conversation measures) and calculate the energy and cost savings associated to each ECM,</li><li>
Developing 2050 zero-emission pathways for buildings or building portfolios,</li><li>
Staying up to date with T&uuml;rkiye, EU and global energy/resource efficiency policies.</li></ul>
 Does this role inspire you?
We're looking for someone who is passionate about advancing energy efficiency and sustainable building design. We also value:<ul><li>
Bachelor's degree in mechanical engineering,</li><li>
Having energy auditor and preferably energy manager certifications from Ministry or Energy and Natural Resources (Certified Energy Auditor - CEA and Certified Energy Manager -CEM),</li><li>
Excellent command of both Turkish and English,</li><li><div>
At least 5 years' experience in combination of the following responsibilities: 
<ul><li>(building) mechanical designer</li><li>energy auditor</li><li>technical engineer working in sustainability, decarbonization or climate change projects.</li></ul></div></li><li>
Have a driver's license,</li><li>
No travel restrictions (national &amp; internationally).</li></ul>
Preferred Qualifications<ul><li>
Competency in OpenStudio (EnergyPlus) building energy modelling software,</li><li>
 Knowledge or competence or building life-cycle assessment,</li><li>
Knowledge of embodied carbon in buildings,</li><li>
Knowledge of solar power, biomass and deep geothermal (renewables),</li><li>
Experience working in global firms, projects funded by IFI's, working with municipalities and ministries is a plus.</li></ul>
Why Arup?
At Arup, we believe in rewarding our members for their contributions to our shared success. As a trust-owned company, we have the freedom to pursue meaningful work that aligns with our purpose and values. We also offer a unique profit share program, allowing our members to share in the results of our collective efforts.
Benefits that work for you:<ul><li>
Professional Growth &amp; Development: Benefit from continuous learning opportunities, training programs, and mentorship to enhance your skills and advance your career at Arup.</li><li>
Global Opportunities: Collaborate with colleagues worldwide and explore potential short-term or long-term assignments at other Arup offices and project locations.</li><li>
Financial Well-being &amp; Ownership: Receive a competitive salary and benefits package and share in Arup's success through our global profit-sharing programme.</li></ul>
At Arup, you belong to an extraordinary collective where individuality is encouraged. Our strength comes from how we respect, share, and connect our diverse experiences, perspectives, and ideas. You'll have the opportunity to do socially useful work that has meaning &ndash; to Arup, to your career, and to the clients and communities we serve.
We are proud to be an equal opportunity employer and are committed to building a workplace that reflects the rich diversity of the world around us. We actively promote a culture of inclusion where everyone feels welcome, respected, and valued.
We welcome applications from talented individuals of all backgrounds, regardless of age (within legal limits), gender identity or expression, disability, ethnicity, religion, sexual orientation, or any other protected characteristic. We are committed to making our recruitment process and workplaces accessible. If you need any assistance or adjustments, please visit our Candidate Support page for contact information and assistance. We're happy to help.
Do you want to join us in shaping a better world?
Apply using the &quot;&quot; button above</div></div><div></div>

Industrial Energy Auditor

KPMG Türkiye

<div>
 
 KPMG is a global network of professional firms providing Audit, Tax and Advisory services. We operate in 142 countries, have more than 275,000 people working in member firms around the World.
 
 KPMG
 
 is the chosen business partner for many of the world&rsquo;s leading organizations.
 
 
 
 
 
 At KPMG, you&rsquo;ll join a team of diverse and dedicated problem solvers, connected by a common cause turning insight into opportunity for clients and communities around the world
 
 .
 
 We place a high value on providing our employees with a supportive and collaborative workplace where people are valued and empowered. In our team you can make a difference.
 
 
 
 
 
 We are now taking applications for Transaction Services (Financial Due Diligence) Manager / Associate Director in our Deal Advisory team.
 
 
 
 
 
 
 The opportunity
 
 
 
 
 
 
 
 In every economic environment, there are opportunities to create, enhance, and preserve value. Our Deal Advisory professionals help buyers, sellers, private equity investors, governments, and lenders in developing and executing on their value strategies. Our clients are typically private corporates, private equity funds, as well as large public companies. Our people are motivated self-starters with expertise in finance, valuation, tax, accounting and financial reporting. Our network is global.
 
 
 
 
 
 KPMG's Deal Advisory practice is continuing to grow and we are currently looking for professionals at the Manager / Associate Director level for Transaction Services (Financial Due Diligence) team. Come and join us.
 
 
 
 
 
 We welcome applications from candidates based in Istanbul and other cities across Turkey.
 
 
 
 
 
 
 What You Will Do
 
 
 
 
 
 
 
 Working in multi-disciplinary teams, you will apply your professional and technical skills on a wide variety of transactions and at different stages of the transaction cycle. As Manager / Associate Director, Transaction Services, you will
 
 
 
 
 <ul>
 <li>
 Manage and deliver financial due diligence projects,
 </li>
 <li>
 Focus on analyzing financial data and identifying key trends behind the performance of a business, discussing business performance and forecast assumptions with senior team management, and lead to write reports that set out our findings and recommendations around the key financial and business issues and will provide value to the client through insights, factual conclusions and advice. Review and analysis of historical trading, cash flow and balance sheets,
 </li>
 <li>
 Perform financial analysis, reading financial tables of a company and identifying KPIs of various sectors,
 </li>
 <li>
 Review of the adequacy of working capital facilities, including consideration of financing limits, term and covenants,
 </li>
 <li>
 Reporting of potential key issues for our client including identification of risk or price affecting consideration,
 </li>
 <li>
 Develop, train and coach junior team members through challenging and meaningful opportunities,
 </li>
 <li>
 Deliver exceptional client service by maximizing results and driving high performance from people, while also fostering collaboration across businesses and borders,
 </li>
 <li>
 Influence clients, teams and individuals positively, leading by example and establishing confident relationships as a representative of KPMG Deal Advisory,
 </li>
 <li>
 Understand key objectives for clients and KPMG, and align people to them to set appropriate priorities and direction.
 </li>
 </ul>
 
 
 
 
 
 Requirements
 
 
 <ul>
 <li>
 Bachelor's degree in accounting, finance, economics, or business from an accredited ,college/university,- preferably an MSc or MA degree from an accredited college/university.
 </li>
 <li>
 5-8 years of experience with a combination of transaction services (financial due diligence), audit, internal audit, financial reporting etc. experience,
 </li>
 <li>
 Strong accounting/audit background preferably in Big4,
 </li>
 <li>
 Professional report writing and presentation skills to assist in preparing pitch documents e.g. proposals and presentations,
 </li>
 <li>
 Excellent verbal and written communication skills in English,
 </li>
 <li>
 Proven ability to deliver the full cycle of project management and manage engagement teams and client deliverables, applying your professional and technical skills on a wide variety of transactions,
 </li>
 <li>
 Experience with project problem diagnosis, solution development, client communications, facilitation of decision making, documentation, managing client expectations and team leadership.
 </li>
 </ul>
 
 
</div>

Transaction Services (Financial Due Diligence) Manager / Associate Director

Explore 622+ Associate director gvp gcp quality assurance auditor in R D Bus Jobs In Istanbul Turkey this December. Find roles across top companies and apply now to boost your career.