Quality Compliance Senior Manager (GCP)

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you're part of something bigger, it's because you are. At Amgen our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.

QUALITY COMPLIANCE SENIOR MANAGER (GCP)

What you will do

• Provide proactive end to end quality support for the development and implementation of a risk-based quality assurance strategy for all stages of products in the clinical development program.
• Serve as a Good Clinical Practices (GCP) Subject Matter Expert, providing independent quality guidance for clinical trials.
• Plan, conduct and report out on risk-based GCP audits (investigator site audits, affiliate audits, service provider audits, and study level audits) or support outsourced audits.
• Manage quality events and regulatory inspections, and advise on responses, including root cause analysis and CAPA plans.
• Ensure quality oversight for the Risk Assessment Categorization Tool (RACT) to identify and mitigate trial risk.
• Support monthly meetings with clinical program leaders to review quality and compliance risks, including deviations, trends, filing timelines, inspections, and cross-program risks.
• Conduct new vendor qualifications in a risk-based manner.
• Analyze data quality trends, address areas of weakness and gaps, implement and communicate key quality metrics.
• Coordinate and support key technologies for data collection and measurement (e.g., biomarker usage and imaging methods).

What we expect of you

• Experience in Quality Management, Quality Assurance, or other relevant risk-based quality practices in the pharmaceutical/biotech industry.
• Expertise in Quality Management Systems (QMS), including electronic systems like Veeva or TrackWise.
• Strong knowledge of Clinical R&D, global regulations and regulatory submissions.
• Quality Oversight of Clinical Trials, including protocol development, execution and submissions.
• Expert within GCP, including conducting audits and managing inspections.
• Excellent communication, active listening, strong analytical and decision-making skills.
• Leadership or mentoring experience is considered a plus.
• Degree educated.

What you can expect of us

• Vast opportunities to learn and move up and across our global organization.
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits.

LOCATION: Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace.

APPLY NOW

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

Equal Opportunity Statement

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.

We will ensure that individuals with disabilities are provided a 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 an accommodation.