director quality assurance

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.
The Associate Director &ndash; Quality Assurance - Operational Readiness is a key site quality leader responsible for ensuring quality readiness of the Houston site as it transitions from project phase to GMP operations. This role provides end-to-end quality leadership to ensure that facilities, utilities, equipment, systems, processes, and teams are inspection-ready, compliant, and capable of sustained GMP execution at startup and beyond.
The role partners closely with Project, Engineering, Operations, TSMS, Regulatory, and Global Quality to embed quality into design, qualification, operational readiness, and execution. The Quality Operational Readiness Lead drives risk-based decision making, governance, and alignment to ensure startup activities meet regulatory, quality, and patient safety expectations while supporting on-time delivery.
Key Responsibilities
Quality Readiness Strategy 
Define and drive the site Quality Operational Readiness strategy to ensure GMP compliance, inspection readiness, and successful regulatory approval. Ensure quality requirements are embedded into design, qualification, validation, and startup activities.
Cross-Functional Alignment 
Partner with Project Management, Engineering, Operations, TSMS, Regulatory, and Global Quality to align quality readiness activities with project milestones and startup timelines. Act as the primary quality interface for site readiness governance.
Quality Systems Establishment 
Partner with other stakeholders within and outside the quality team, to the establish and execute the site Quality Management Systems (e.g., deviations, change control, document management, training) to support initial licensure and sustainable operations.
Risk Identification and Mitigation 
Identify, assess, and mitigate quality and compliance risks through structured risk assessments, readiness reviews, and escalation mechanisms. Ensure timely resolution of gaps impacting startup or regulatory commitments.
Execution Readiness &amp; Performance Monitoring 
Define readiness metrics, dashboards, and governance routines to track progress and ensure accountability. Drive disciplined execution of quality deliverables across all startup phases.
Capability Building &amp; Leadership 
Support building and developing the site Quality organization through effective staffing, training, coaching, and knowledge transfer. Foster a strong &ldquo;Safety First &amp; Quality Always&rdquo; mindset from project phase through commercial operations.
Requirements<ul><li>
Bachelor&rsquo;s degree in a scientific, engineering, or related discipline.</li><li>
8+ years of experience in Quality within regulated GMP environments (Pharma, Biotech, or Medical Devices).</li><li>
Demonstrated experience supporting site startups, major expansions, or large capital projects from a Quality perspective.</li><li>
Strong working knowledge of GMP regulations, inspection readiness, validation, and quality systems.</li></ul>
Additional Preferences<ul><li>
Prior experience in greenfield or brownfield manufacturing startups.</li><li>
Experience working with regulatory submissions, approvals, and pre-approval inspections.</li><li>
Strong understanding of aseptic manufacturing, utilities, equipment qualification, and data integrity principles (preferred for parenteral facilities).</li><li>
Proven ability to lead through ambiguity, manage competing priorities, and make risk-based quality decisions under time pressure.</li><li>
Excellent communication and stakeholder management skills, with the ability to influence across functions and levels.</li><li>
Collaborative leadership style with the ability to balance compliance, speed, and business needs.</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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. 
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women&rsquo;s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate&rsquo;s education, experience, skills, and geographic location. The anticipated wage for this position is
$123,000 - $180,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly&rsquo;s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly</div>

Associate Director – Quality Assurance - Operational Readiness

Corbus Pharmaceuticals

<div>Description: 
The Director, Clinical Quality Assurance, reporting directly to the Senior Director, Head of Quality, will be responsible for all aspects of Quality Assurance focused on Good Clinical Practice (GCP) activities to ensure quality assurance and compliance of Corbus sponsored clinical trials (Early-Late Phase) with applicable GCP regulations (e.g., FDA, ex-US, country-specific), ICH GCP guidelines, Corbus Standard Operating Procedures (SOPs), and current industry standards and practices. Activities will generally fall under the following clinical QA areas: Vendor Quality, QA audit program, Corbus quality systems, and internal/clinical study team support.
The Director, Clinical QA will establish, maintain, and ensure effectiveness of quality programs and documentation to assure GCP compliance and inspection readiness with regards to all quality requirements, and regulatory standards while supporting continuous clinical supply and delivery expectations. The ideal candidate will be based in the Boston area with 3 days in office in Norwood, MA.
Essential Functions and Duties:<ul><li>
Work collaboratively with the internal Corbus Clinical Operations Team to ensure compliance standards are achieved.</li><li>
Manage the GCP Quality interface and support for all Clinical Project Teams.</li><li>
Identify and access compliance risk and develop and implement risk mitigation measures.</li><li>
Manage GCP audit program to include routine and non-routine quality assurance audits of clinical investigator sites, vendors, processes, systems, and study documents to ensure integrity and accuracy of study data and assure quality compliance with internal procedures as well as regulatory guidelines.</li><li>
Review and approve Clinical SOPs.</li><li>
Develop and Implement Clinical QA SOPs.</li><li>
Develop and implement detailed audit plans and yearly GCP audit schedules.</li><li>
Ensure the timely and effective follow up of all identified or assigned quality issues.</li><li>
Conduct QA oversight of GCP protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), and other clinical trial specific documents as requested.</li><li>
Prepare written audit reports and communicate findings and recommendations and evaluate the adequacy and completeness of corrective and preventative action plans.</li><li>
Direct and/or deliver yearly GCP training for internal staff as needed.</li><li>
Work closely with Clinical Development, Clinical Operations, and other clinical functions/departments to ensure compliance readiness.</li><li>
Provide leadership in inspection preparedness to clinical sites and vendors for regulatory government agencies.</li><li>
Provide management reports on audit strategy, plans, and findings</li><li>
Support process improvement initiatives; lead continuous improvements within Quality.</li><li>
Maintain knowledge of GCP regulations, guidelines, company standards and procedures.</li><li>
Preferred experience in providing oversight and supporting GLP related studies</li></ul>
Requirements:

Education and Experience:<ul><li>
12+ years relevant work experience within the GxP (GCP heavy) Biotechnology/Pharmaceutical industry.</li><li>
Scientific or engineering degree (BSc, MSc, PhD), Min Bachelor of Science Degree in Biology, Biomedical Engineering, Engineering, or equivalent</li></ul>
Knowledge, Skills, and Abilities:<ul><li>
Knowledge of Good Clinical Practice (GCP) FDA, MHRA and EMA regulatory requirements applicable to Biologics therapy products.</li><li>
Very good scientific and medical/clinical expertise.</li><li>
Solid expertise in GCP and ICH clinical requirements, clinical development and methodologies of clinical studies.</li><li>
Effective communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies.</li><li>
Must have ability to utilize knowledge and interpersonal skills to provide direction and development cross-functionally and regionally, at all organization levels</li><li>
Well organized and detail-oriented; must be able to effectively prioritize work</li><li>
Eager to learn, interact cooperatively and effectively with others in a team environment</li><li>
Possess advanced word processing, data entry and data presentation computer skills</li><li>
Ability to influence and work effectively with business partners across regions and cultures</li><li>
Displays organizational leadership qualities and effective coaching abilities.</li><li>
Listening, interpreting, and summarizing information skills must be highly developed.</li><li>
Ability to work both independently with direction and within project teams to attain goals.</li><li>
Expertise in reviewing, revising, and writing Standard Operating Procedures (SOPs).</li><li>
Proven ability to manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines.</li><li>
Strong organizational skills and the ability to participate effectively cross-functionally.</li><li>
Ability to build consensus among colleagues with an appropriate level of flexibility, while maintaining a focus on results and goal attainment.</li><li>
Fluency in written and spoken English. Fluency in Chinese is a plus.</li><li>
Demonstrated ability to lead on-site corporate, external, or Health Authority inspections</li><li>
A self-starter and a team player who thrives in a fast-paced dynamic team environment.</li><li>
Proficiency in using Veeva Clinical and Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint). Veeva Quality is a plus.</li></ul>
LICENSES/CERTIFICATIONS:<ul><li>
Certification as an auditor by an organization recognized is desirable within the pharmaceutical industry.</li></ul>
TRAVEL REQUIREMENTS:<ul><li>
Willingness to travel to various meetings/audits, may include overnight trips. Some international travel may be required.</li><li>
May require approximately 10-25% travel</li></ul>
Corbus Culture:
Corbus is a close-knit team of high-achieving, innovative, creative and, above all else, passionate employees. We hire for personality as well as for skill. At Corbus, we take pride in our &ldquo;family&rdquo; atmosphere where each person&rsquo;s contribution is vital to our success. As a Corbus employee, you are empowered to think creatively and be proactive in your approach. There is no place for politics or red tape here.
About Corbus;
Corbus Pharmaceuticals Holdings, Inc. is a clinical-stage company focused on oncology and obesity and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on X, LinkedIn and Facebook.
Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer</div>

Director, Clinical Quality Assurance (GCP)

Samuel Knight Energy & Infrastructure

<div>
 
 The Director of Data Center Construction Quality is responsible for managing the quality of the project (NTP to COD) to ensure the project is constructed and performs in accordance with the established requirements and standards. The qualified candidate will work closely with the SB Energy Project Manager and the EPC&rsquo;s Quality and Construction Manager to ensure all goals are achieved. The role also includes direct oversight and review of the entire documentation and physical inspection phase of the workflow process and collaborating with other in-house personnel (e.g.: Construction Manager, Project Engineer etc.) and external personnel to produce and document a quality product. This role will report directly to the VP of Operational Excellence and secondary reporting to the VP of Data Center Projects.
 
 
 
 
 
 
 Qualifications:
 
 
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in Engineering (Electrical, Mechanical, or Structural required)
 </li>
 <li>
 12+ years in quality, engineering, commissioning, or construction leadership within: Data centers, Semiconductor fabs, Power generation or other mission-critical infrastructure
 </li>
 <li>
 Demonstrated authority interacting with EPCs, designers, and hyperscale clients
 </li>
 <li>
 Proven ability to identify latent defects and systemic risks before they reach operations
 </li>
 </ul>
 
 
 
 
 
 Preferred:
 
 
 
 
 
 <ul>
 <li>
 PE license
 </li>
 <li>
 Commissioning or quality certifications (CxA, PMP, ISO lead auditor, etc.)
 </li>
 <li>
 Experience in design-build and fast-track delivery models
 </li>
 </ul>
 
 
 
 
 
 Technical Requirements
 
 
 
 
 
 <ul>
 <li>
 Mission-critical electrical systems up to and including medium-voltage distribution
 </li>
 <li>
 Mechanical cooling systems for high-density and liquid-cooled environments
 </li>
 <li>
 Redundancy architectures (N, N+1, 2N, distributed redundancy)
 </li>
 <li>
 Commissioning methodologies and failure-mode testing
 </li>
 <li>
 Applicable codes and standards:
 </li>
 <li>
 NEC, NFPA, IBC, IFC
 </li>
 <li>
 IEEE, ASHRAE, ASME
 </li>
 <li>
 Uptime Institute / TIA-942 concepts (formal certification not required)
 </li>
 </ul>
 
 
 
 
 
 SALARY &ndash; 190,000 &ndash; 220,000
 
 
 
 
 
 <ul>
 <li>
 100% Company-Paid Medical, Dental &amp; Vision (for employees and dependents)
 </li>
 <li>
 401(k) with Company Match
 </li>
 <li>
 Generous Paid Time Off + 11 Paid Holidays
 </li>
 <li>
 12 Weeks Paid Parental Leave
 </li>
 <li>
 PLUS MORE
 </li>
 </ul>
 
 
 
 
 
 Location:
 
 San Francisco/Bay Area, CA or TX is preferred. Hybrid.
 
</div>

Director of Quality Assurance

Organon Pharmaceuticals

<div>The position
The Associate Director, Pharmacovigilance (PV) 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 PV 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 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 PV 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) year of experience in PV auditing with EU/FDA /global regulatory requirements.</li><li>
Strong knowledge of EMA, FDA and ICH guidelines in 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><li>
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.</li><li>
Communication Skills: Strong verbal skills and experienced effective writing skills.</li><li>
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.</li><li>
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.</li><li>
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.</li></ul>
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:
No
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:R539374</div>

Associate Director, Pharmacovigilance Quality Assurance Auditor

HRPSP - Your Strategic HR Partner

Job Opportunity &mdash; Executive (Quality Assurance) Locations: QuettaSalary Range: PKR 80,000We are looking for a dynamic and experienced professional to join our team as an Executive &ndash; Quality Assurance. The ideal candidate will have strong technical expertise in FTTH along with proven leadership skills to manage field operations and ensure quality service delivery.Key Responsibilities:<ul><li>Lead and manage FTTH field teams to ensure timely and high-quality deployment</li><li>Monitor and enhance quality standards across installations and maintenance activities</li><li>Conduct regular quality audits and ensure compliance with SOPs and company standards</li><li>Coordinate with planning, deployment, and vendor teams to meet project timelines and SLAs</li><li>Troubleshoot and resolve complex fiber-related issues escalated from field teams</li><li>Maintain QA reports, checklists, and performance scorecards</li><li>Liaise with relevant authorities to resolve Right of Way (ROW) issues</li><li>Ensure compliance with health, safety, and operational guidelines</li><li>Prepare progress reports, maintain documentation, and track KPIs</li><li>Drive continuous improvement to enhance customer experience and operational efficiency</li></ul>Requirements:<ul><li>Minimum 16 years Degree in Electrical, Electronics, Telecom, or related field</li><li>2&ndash;5 years of experience in FTTH, specifically in Quality, Deployment or Field Operations</li></ul>Job Type: Full-timePay: Rs80,000.00 per monthWork Location: In person

Executive (Quality Assurance)

Job Opportunity &mdash; Executive (Quality Assurance) Locations: FaisalabadSalary Range: PKR 80,000We are looking for a dynamic and experienced professional to join our team as an Executive &ndash; Quality Assurance. The ideal candidate will have strong technical expertise in FTTH along with proven leadership skills to manage field operations and ensure quality service delivery.Key Responsibilities:<ul><li>Lead and manage FTTH field teams to ensure timely and high-quality deployment</li><li>Monitor and enhance quality standards across installations and maintenance activities</li><li>Conduct regular quality audits and ensure compliance with SOPs and company standards</li><li>Coordinate with planning, deployment, and vendor teams to meet project timelines and SLAs</li><li>Troubleshoot and resolve complex fiber-related issues escalated from field teams</li><li>Maintain QA reports, checklists, and performance scorecards</li><li>Liaise with relevant authorities to resolve Right of Way (ROW) issues</li><li>Ensure compliance with health, safety, and operational guidelines</li><li>Prepare progress reports, maintain documentation, and track KPIs</li><li>Drive continuous improvement to enhance customer experience and operational efficiency</li></ul>Requirements:<ul><li>Minimum 16 years Degree in Electrical, Electronics, Telecom, or related field</li><li>2&ndash;5 years of experience in FTTH, specifically in Quality, Deployment or Field Operations</li></ul>Job Type: Full-timePay: Rs80,000.00 per monthWork Location: In person

Job Opportunity &mdash; Executive (Quality Assurance) Locations: SialkotSalary Range: PKR 80,000We are looking for a dynamic and experienced professional to join our team as an Executive &ndash; Quality Assurance. The ideal candidate will have strong technical expertise in FTTH along with proven leadership skills to manage field operations and ensure quality service delivery.Key Responsibilities:<ul><li>Lead and manage FTTH field teams to ensure timely and high-quality deployment</li><li>Monitor and enhance quality standards across installations and maintenance activities</li><li>Conduct regular quality audits and ensure compliance with SOPs and company standards</li><li>Coordinate with planning, deployment, and vendor teams to meet project timelines and SLAs</li><li>Troubleshoot and resolve complex fiber-related issues escalated from field teams</li><li>Maintain QA reports, checklists, and performance scorecards</li><li>Liaise with relevant authorities to resolve Right of Way (ROW) issues</li><li>Ensure compliance with health, safety, and operational guidelines</li><li>Prepare progress reports, maintain documentation, and track KPIs</li><li>Drive continuous improvement to enhance customer experience and operational efficiency</li></ul>Requirements:<ul><li>Minimum 16 years Degree in Electrical, Electronics, Telecom, or related field</li><li>2&ndash;5 years of experience in FTTH, specifically in Quality, Deployment or Field Operations</li></ul>Job Type: Full-timePay: Rs80,000.00 per monthWork Location: In person

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Associate Director – Quality Assurance - Operational Readiness

Director, Clinical Quality Assurance (GCP)

Director of Quality Assurance

Associate Director, Pharmacovigilance Quality Assurance Auditor

Executive (Quality Assurance)

Executive (Quality Assurance)

Executive (Quality Assurance)