quality compliance manager

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.
Quality Compliance Manager
What you will do
Let&rsquo;s do this! Let&rsquo;s change the world!
We are hiring a Quality Compliance Manager, which will operate within the General Medicine &amp; Obesity Quality Therapeutic Area.
In this vital role you will provide proactive end to end quality support for the development and implementation of a risk-based quality assurance strategy that advances quality by design principles for the full clinical development program. (protocol development, database lock, and regulatory submissions/ approvals).
Reporting to the Quality Compliance Associate Director, you will oversee quality management and ensure compliance for global and local clinical trials by supporting study teams and trial sites involved in Amgen-sponsored Trials.
Responsibilities<ul><li>
GCP Subject Matter Expert - Provide independent and objective quality advice in support of clinical trial activities and in line with current standard methodology.</li><li>
Provide quality oversight for Amgen programs for all stages of products in clinical development</li><li>
Ensure quality oversight for the Risk Assessment Categorization Tool (RACT) for each trial to guarantee the proper identification, prioritization, and mitigation of risks to critical data and processes and patient safety, welfare and rights</li><li>
Support the establishment of regional expertise to ensure quality and compliance to local Regulations</li><li>
Support Clinical Trial Teams for all quality management activities, including Deviations/CAPAs, Inspection Readiness and Management activities, and Serious Breaches/ Privacy Issues</li><li>
Ensure TA-specific data integrity, including technologies for data collection and measurement (e.g., biomarker usage and imaging methods)</li><li>
Review clinical trial protocols ensuring simplification, application of lessons learned, and identification of critical data and processes</li><li>
Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-methods leveraging AI and Natural Language Processing, and other advanced data analytics methods)</li><li>
Manage/support regulatory inspection and review responses.</li><li>
Prepare, analyze and Identify data quality indicators/trends, identify areas of weakness/gaps, recommend and implement corrective actions and communicate quality metrics and other significant quality information on periodic basis to key partners</li><li>
Support Monthly meetings with program level CPO senior management/associate directors to review, but not limited to, the following: ongoing quality issues, quality trends, program filing timelines and potential inspections.</li><li>
Support response generation for audit findings and self reported deviations.</li><li>
Support the establishment of regional expertise to ensure quality and compliance to local regulations</li><li>
Provide Study Specific Vendor Quality Oversight</li><li>
Plan, conduct and report out on risk-based Good Clinical Practices (GCP) audits (investigator site audits, affiliate audits, and study level audits)</li></ul>
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:
Basic Qualifications:<ul><li>
Doctorate degree OR</li><li>
Master&rsquo;s degree and 2 years of quality management experience OR</li><li>
Bachelor&rsquo;s degree and 4 years of quality management experience OR</li><li>
Associate&rsquo;s degree and 8 years of quality management experience OR</li><li>
High school diploma / GED and 10 years of quality management experience</li></ul>
Preferred Qualifications:<ul><li>
Experience in Quality Management, Quality Assurance or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility</li><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>
Knowledge of the Regulatory Submission and Inspection Management procedures.</li><li>
Quality Oversight of Clinical Trials, including clinical trial protocol development, execution, and submissions.</li><li>
Excellent verbal and written communication skills, including strong business writing abilities and active listening.</li><li>
Ability to transform business and team member feedback into clear, efficient processes using a straightforward language and format.</li><li>
Strong analytical, critical-thinking, and decision-making abilities.</li><li>
Capability to understand and articulate technical concepts and literature in spoken and written English.</li></ul>
What you can expect from us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we&rsquo;ll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:<ul><li>
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts</li><li>
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan</li><li>
Stock-based long-term incentives</li><li>
Award-winning time-off plans</li><li>
Flexible work models, including remote and hybrid work arrangements, where possible</li></ul>
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.</div>

Quality Compliance Manager

<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.
GCP Quality Compliance Manager
What you will do
Let&rsquo;s do this! Let&rsquo;s change the world! In this vital role you will provide critical support to the Process Quality function by assisting in the implementation, monitoring, and continuous improvement of Amgen&rsquo;s R&amp;D Quality Management System (QMS).
Accountabilities:
<ul><li>Assist in maintaining and improving the QMS by helping to track, document, and implement quality initiatives, ensuring that procedures and processes meet regulatory requirements.</li><li>
Contribute to the collection, analysis, and reporting of quality metrics (KPIs, KQIs), helping to identify trends, risks, and areas for continuous improvement.</li><li>
Provide hands-on support to the Senior Manager in ensuring procedural compliance with GCP standards and other regulatory requirements across R&amp;D.</li><li>
Act as a liaison between the Process Quality function and Global Networks supporting smooth collaboration and exchange of information.</li><li>
Provide support for Serious Breach Process</li><li>
Perform risk assessments of process, vendors and functions</li><li>
Identify data quality indicators/trends, identify areas of weakness/gaps, recommend and implement corrective actions</li><li>
Coordinate activities related to site/sponsor inspections and audits - preparation, conduct and close out and response generation</li></ul>
Key Capabilities:<ul><li>
Understanding of SOP/Standards management and methods/technology used to drive knowledge management across a diverse R&amp;D environment</li><li>
Communicate effectively</li><li>
Develops innovative and creative output based on interpretation and analysis</li><li>
In-depth disciplinary knowledge; uses business insight and subject matter expertise</li><li>
Employs project management techniques</li><li>
Thorough understanding of business priorities, strategy and direction</li><li>
Integrates trends, data and information into plans, deliverables and recommendations</li><li>
Manages root cause analysis and corrective/prevent action completion follow-up</li><li>
Acts as a technical expert in GCP</li><li>
Employs critical thinking skills</li><li>
Able to separate critical from non-critical issues</li><li>
Strong attention to detail and proficiency in managing data and reports.</li><li>
Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-methods leveraging AI and Natural Language Processing, and other advanced data analytics methods).</li></ul>
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.
Basic Qualifications:<ul><li>
Doctorate degree OR</li><li>
Master&rsquo;s degree and 2 years of Quality/Compliance/Process Management experience OR</li><li>
Bachelor&rsquo;s degree and 4 years of Quality/Compliance/Process Management experience OR</li><li>
Associate&rsquo;s degree and 8 years of Quality/Compliance/Process Management experience Or</li><li>
High school diploma / GED and 10 years of Quality/Compliance/Process Management experience</li></ul>
Preferred Qualifications:<ul><li>
2 years or more experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality management and quality by design are a core responsibility.</li><li>
Solid understanding of SOP/Standards management and methods/ technology used to drive knowledge management across a diverse R&amp;D environment.</li><li>
Thorough understanding of Clinical R&amp;D activities and Global Regulations.</li><li>
Strong analytical, critical thinking, and decision-making abilities.</li><li>
Strong Process Mind and analytically oriented - experience with process monitoring, including applying analytical methods and modern technology to enable signal detection and quality improvement.</li><li>
Proven team player &ndash; takes direction and can rapidly learn and support a hard-working team, making rapid decisions and communicating them promptly.</li><li>
Excellent verbal and written communication skills - demonstrates strong business writing abilities and active listening.</li><li>
Capability to understand and articulate technical concepts and literature in spoken and written English.</li></ul>
What you can expect from us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we&rsquo;ll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:<ul><li>
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts</li><li>
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan</li><li>
Stock-based long-term incentives</li><li>
Award-winning time-off plans</li><li>
Flexible work models, including remote and hybrid work arrangements, where possible</li></ul>
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.</div>

GCP Quality Compliance Manager

Duncan Aviation

The Quality Compliance Manager &ndash; Manufacturing is responsible for administering and overseeing the Company&rsquo;s Quality Assurance System for Parts Manufacturer Approval (PMA), Non-Repair Station fabrication through the Quality Management System (QMS), and Repair Station fabricated parts, including parts fabricated for Supplemental Type Certificate (STC) development projects. This position also ensures compliance with the Quality Control Programs for government and customer contracts.
 <div>COMPANY DESCRIPTION:<div>
Duncan Aviation is the largest, family-owned maintenance, repair and overhaul (MRO) facility in the world providing complete nose-to-tail services for business aircraft. We value the individual experiences and diversity of our workforce and are proud to be a Veteran-Friendly Employer. Individuals of all backgrounds, nationalities, disability status, and military service are encouraged to apply.
Are you ready for an Experience. Unlike any other? Apply today!</div></div>
 Duncan Aviation is an Equal Opportunity and Affirmative Action Employer. EOE Minorities/Females/Protected Veterans/Disabled

QUALITY COMPLIANCE MANAGER-MANUFACTURING

MERED

A leading construction company in Dubai seeks a Quality Control Manager to organize processes to meet quality standards. Key responsibilities include implementing inspections, monitoring compliance, and managing QA/QC tasks. Candidates should possess a degree in civil engineering and 5+ years of experience in similar roles within the UAE. Competitive salary, benefits, and opportunities for professional development are offered.

Construction QA/QC Manager: Quality & Compliance

Mace Oman

Job Title Compliance and Assurance Manager - Quality Management Dubai Job Description Compliance and Assurance Manager - Quality Management Dubai Position Overview Mace is seeking an experienced Compliance and Assurance Manager to join our consultancy division in Dubai. This role ensures that our quality management system aligns with business, legal, and contractual requirements, supporting ISO certifications and promoting risk mitigation strategies. The position is ideal for professionals passionate about driving compliance, quality, and operational excellence across complex projects in the UAE construction and consultancy sector. Job Details Job Location: Dubai, United Arab Emirates Industry: Construction Function: Compliance / Risk Management Gender: Any Candidate Nationality: Any Job Type: Full Time What You ll Do * Oversee implementation of Mace s quality management system across assigned hubs. * Manage external ISO 9001 certification audits and support new certification processes. * Conduct internal audits, prepare reports, and track follow-up actions. * Investigate non-conformances, identify root causes, and recommend corrective and preventive measures. * Maintain and improve quality management system content, processes, and performance metrics. * Deliver accurate quality reporting, data analysis, and risk mitigation recommendations. * Prepare communication materials for management reviews and business updates. * Monitor supply chain quality performance and provide guidance to ensure compliance. * Develop and deliver training programs to enhance system awareness and implementation. * Support business development by embedding compliance standards and ensuring operational integrity. Ideal Profile * Bachelor s degree in a relevant field. * Strong understanding of quality management principles and operational controls. * Expertise in ISO 9001 standards and compliance requirements. * Experience in internal auditing, certification processes, and system improvements. * Skilled in using digital control tools and project management systems. * Knowledge of project lifecycle controls, from design through delivery. * Ability to work with outsourced business models and complex stakeholder environments. Why Join Us * Opportunity to work on world-class projects with a globally recognized consultancy. * A culture that promotes safety, integrity, and continuous improvement. * Competitive compensation and opportunities for career growth within an international organization.

Compliance and Assurance Manager - Quality Management

Zoroco Packaging Inc.

Join our Team Today! If you are passionate about ensuring product excellence in the food industry, we invite you to apply today and be a part of our dedicated team at Zoroco Packaging Inc.!Job Summary:The Quality Assurance and Compliance Manager is responsible for directing and coordinating all functions of Quality and Compliance for the location, maintaining quality standards, updating HACCP and Food security plans, managing quality teams, and communicating with other departments.Essential Duties and Responsibilities: A Quality Assurance and Compliance Manager is expected to perform one or more of the following essential job functions based on the business assignment (detailed):<ul><li>Oversees all food safety and quality policies, plans, and direction of the facilities Quality and Compliance Department.</li><li>Collaborate with the HR team on the Quality and Compliance training plan for all plant employees; and Manage the Quality and Compliance training and monitor progress for the Quality and Compliance Team.</li><li>Be an active member of the BRC and the HACCP teams.</li><li>Review, investigate and report out on Customer Complaints.</li><li>Identifies opportunities for improvement in all phases of food safety and quality.</li><li>Responsible for water quality program, including monthly sampling and reporting.</li><li>Responsible for overseeing Sanitation Team.</li><li>Develops and maintains SOP&rsquo;s for Sanitation Training and cleaning supplies purchasing orders.</li><li>Manages the HACCP plans and is the primary contact with the USDA and other regulatory officials.</li><li>Attends all audits and will answer all non-QA/Compliances.</li><li>Maintains direct communication with any vendor or supplier of chemical purchasing, pest control, and outside supplier of ingredient labels.</li><li>Develops and maintains written instructions for all Quality tech tasks.</li><li>Responsible for overseeing the annual internal audit.</li><li>Responsible for following the performance evaluation plan and completing the evaluation requirements for all positions in the Department.</li><li>Other Duties as assigned.</li></ul>Required Skills / Abilities / Qualifications:<ul><li>Must be proficient in English.</li><li>USDA HACCP certified.</li><li>GFSI knowledgeable</li><li>Four plus year&rsquo;s experience in a managerial role in a related industry with proven expertise.</li><li>Excellent interpersonal skills and communication with all levels of management and coworkers.</li><li>Strong technical understanding of food manufacturing process flow.</li><li>Solid interpersonal skills demonstrated by the crew's ability to interpret complex assignments into working actions.</li><li>Strong understanding of food processing, food sanitation, food safety, worker safety, and cost development.</li><li>Ability to envision results based on conceptual ideas presented by others.</li><li>Demonstrated ability to improve underperforming processes, resulting in cost benefits to the company.</li><li>LEAN leadership expertise and experience preferred.</li><li>Motivate, lead, gather, and understand information provided by all levels of workers.</li></ul>Supervisory Responsibilities:Directly supervises 3 to 5 Quality Assurance &amp; Compliance Department employees, including the Sanitation Group. Carries out supervisory responsibilities by the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems; manage the time control system according to system permits.Education and/or Experience: Bachelor's degree from a four-year college or university; or one to two years related experience and/or training; or equivalent combination of education and experience.Physical Requirements:While performing the duties of this job, the employee is regularly required to stand. The employee is frequently required to walk; use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee is occasionally required to sit; climb or balance; stoop, kneel, crouch, and taste or smell. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.Working Conditions:While performing the duties of this job, the employee is regularly exposed to wet and/or humid conditions and moving mechanical parts. The employee is occasionally exposed to fumes or airborne particles; some areas of the manufacturing location could be extremely cold or hot. The noise level in the work environment is usually moderate to high; some areas require noise protection.Job Type: Full-timePay: $66,000.00 - $76,000.00 per yearBenefits:<ul><li>401(k)</li><li>401(k) matching</li><li>Dental insurance</li><li>Flexible spending account</li><li>Health insurance</li><li>Life insurance</li><li>Paid time off</li><li>Retirement plan</li><li>Vision insurance</li></ul>Work Location: In person

Quality Assurance and Compliance Manager

UAE General Civil Aviation Authority (GCAA)

<div>
 
 
 Quality &amp; Compliance
 
 
 <ul>
 <li>
 Provide support in the development of Quality policies and procedures and ensure that all processes in place are in line with the approved policies and procedures.
 </li>
 <li>
 Ascertain the extent of compliance with established policies, plans and procedures. Investigate and recommend action to be taken where there are weaknesses in Quality system control.
 </li>
 <li>
 Report observations and findings to the line manager in order to enhance the value of the Quality Assurance process through continuous improvement and corrective actions.
 </li>
 <li>
 Support in providing recommendations for increasing the operating effectiveness of specific procedures.
 </li>
 </ul>
 
 
 Self and External Assessment
 
 
 <ul>
 <li>
 Coordinate and review surveillance/assessment audit reports. Assess gaps and weaknesses in integrated management system and develop countermeasures identifying continuous improvement projects through internal/external audit triggers.
 </li>
 <li>
 Review assessment reports to ensure that the relevant action plans are undertaken by process owners. Monitor and report on progress to ensure that gaps are closed.
 </li>
 </ul>
 
 
 System Compliance
 
 
 <ul>
 <li>
 Implement and administer a compliance management system to support the organisation towards the desired continuous improvement.
 </li>
 </ul>
 
 
 Quality Assurance Methods and Techniques
 
 
 <ul>
 <li>
 Establish techniques within the available methodology and develop these techniques to suit our culture and requirement on an on-going basis.
 </li>
 <li>
 Support the Continuous Improvement activity with the 7 basic Quality Tools and a range of moderately advanced tools.
 </li>
 </ul>
 
 
 Policies, Procedures and Manuals
 
 
 <ul>
 <li>
 Conduct quality assurance reviews of relevant manuals to ensure that all the required information is captured for external and internal users.
 </li>
 </ul>
 
 
 Analysis and Monitoring
 
 
 <ul>
 <li>
 Perform data analyses, identify improvement opportunities by identifying barriers and root causes of issues and service with view to enhancing the overall assurance performance.
 </li>
 <li>
 Monitor the enhancements of post implementation actions proposed within the quality assurance process.
 </li>
 <li>
 Identify and recommend procedures and workflow improvements.
 </li>
 </ul>
 
 
 Quality Assurance Standards
 
 
 <ul>
 <li>
 Ensure that all internal standards are in line with local and international quality and excellence standards.
 </li>
 <li>
 Research best practices to impact quality assurance initiatives and utilisation standards.
 </li>
 <li>
 Update job knowledge by studying trends and developments in quality assurance, participating in educational opportunities, reading professional publications, and participating in professional organisations.
 </li>
 <li>
 Provide effective communication regarding issues, objectives, initiatives, and performance of quality assurance process.
 </li>
 </ul>
 
 
 Reporting
 
 
 <ul>
 <li>
 Ensure that all functional reports are prepared timely and accurately and meet GCAA requirements and quality standards.
 </li>
 </ul>
 
 
 Health, Safety and Environment within GCAA
 
 
 <ul>
 <li>
 Ensure compliance with all relevant health, safety, quality and environmental management procedures and controls to guarantee employee safety, legislative compliance, delivery of high-quality products/services and a responsible environmental attitude as per IMS available standards
 </li>
 </ul>
 
 
 Other Tasks/ Accountability
 
 
 <ul>
 <li>
 Perform additional tasks relevant to the role / area of expertise as requested by the management to be able to achieve the objectives/commitments.
 </li>
 </ul>
 
 
 
</div>

Officer - Quality & Compliance

Search 10000+ Quality compliance manager jobs near you this November. New roles added regularly across leading industries. Apply today.