Quality Compliance, Director
About The Position
Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’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’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. QUALITY COMPLIANCE, DIRECTOR What you will do Let’s do this. Let’s change the world. In this vital role you will report to the Executive Director of Regulatory Compliance and primarily provide direct support for compliance related deliverables associated to new sites or expansion of existing manufacturing sites. Serve as a strategic partner supporting the Quality Improvement Plans (QIP) and Operational Readiness program by providing independent compliance expertise, and objective guidance to support sustained GMP readiness and operational excellence. Partner closely with QA Operational Readiness Team and cross-functional leadership to evaluate remediation strategies, operational readiness initiatives, and quality system enhancements, ensuring alignment with global quality standards, regulatory expectations, and enterprise best practices. Participate in operational readiness reviews, and Go/No-Go decision-making processes to support objective, evidence-based assessments while promoting inspection readiness, effective risk management, and the long-term sustainability of the site's Quality Management System. Draft and/or review regulatory communications in the form of inspection observation responses, third party audit finding responses, responses to questions associated with regulatory filings and other information requests. Conduct inspection readiness exercises (strategy, preparation, pressure testing) in support of both scheduled and unscheduled regulatory inspections, in coordination with the sites and Site Inspection Lifecycle Management staff. Assist with generation of inspection playbooks and ensure staff are prepared to present during regulatory inspections. Lead virtual or on-site strategy support during regulatory inspections. May lead cross-functional regulatory response teams. Provide direct compliance support for deviation investigation and key inspection topics. Ensure appropriate technical content and documented rationale is available in support of investigation conclusions. Participate on Investigation Advisory Boards as Advisor, as required. Provide compliance advice on new technologies and proposed changes to quality processes in support of continuous improvement and the implementation of new digital strategies.
Requirements
- Bachelor’s degree and 9 years of Quality Compliance experience OR
- Master’s degree and 7 years of Quality Compliance experience OR
- Doctorate degree and 4 years of Quality Compliance experience
Nice To Haves
- Strong background in Quality Compliance within a GMP-regulated environment.
- Experience supporting drug substance and bulk manufacturing operations.
- Expertise in GMP compliance, inspection readiness, and regulatory requirements.
- Experience with drug product manufacturing and compliance.
Responsibilities
- Serve as a strategic partner supporting the Quality Improvement Plans (QIP) and Operational Readiness program by providing independent compliance expertise, and objective guidance to support sustained GMP readiness and operational excellence.
- Partner closely with QA Operational Readiness Team and cross-functional leadership to evaluate remediation strategies, operational readiness initiatives, and quality system enhancements, ensuring alignment with global quality standards, regulatory expectations, and enterprise best practices.
- Participate in operational readiness reviews, and Go/No-Go decision-making processes to support objective, evidence-based assessments while promoting inspection readiness, effective risk management, and the long-term sustainability of the site's Quality Management System.
- Draft and/or review regulatory communications in the form of inspection observation responses, third party audit finding responses, responses to questions associated with regulatory filings and other information requests.
- Conduct inspection readiness exercises (strategy, preparation, pressure testing) in support of both scheduled and unscheduled regulatory inspections, in coordination with the sites and Site Inspection Lifecycle Management staff.
- Assist with generation of inspection playbooks and ensure staff are prepared to present during regulatory inspections.
- Lead virtual or on-site strategy support during regulatory inspections. May lead cross-functional regulatory response teams.
- Provide direct compliance support for deviation investigation and key inspection topics. Ensure appropriate technical content and documented rationale is available in support of investigation conclusions. Participate on Investigation Advisory Boards as Advisor, as required.
- Provide compliance advice on new technologies and proposed changes to quality processes in support of continuous improvement and the implementation of new digital strategies.
Benefits
- 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
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible.
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What This Job Offers
Job Type
Full-time
Career Level
Director
