Quality Compliance Senior Manager - Inspections (GCP)

Amgen SA; Cambridge; Hybrid; GBP 50,000 - 90,000

Job description

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 - INSPECTIONS (GCP)

What you will do

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, for all stages of products in the clinical development program. This role focuses on preparation and management for Regulatory Inspections and advise on responses, including root cause analysis and CAPA plans.

• 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
• Support global and local clinical trial teams for all quality management activities, including management of quality events (e.g., Deviations/CAPAs, Serious Breaches/Privacy Issues, Inspection Readiness activities, and Inspection Management)
• 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)

Be part of our team

You will join a global, dynamic and expanding team, operating within one of the following therapy areas: Oncology, Rare Disease, General Medicine, Biosimilars and Inflammation. You will report to the Therapeutic Area Quality Lead - Clinical & Research Quality (CRQ).

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:

• Experience in Quality Management, Quality Assurance, or other relevant risk-based quality practices in the pharmaceutical/biotech industry
• Quality Oversight of Clinical Trials, including protocol development, execution and submissions
• Expert in GCP with extensive experience in inspection planning, including timeline management, mock inspections, and interview preparation.
• Expertise in Quality Management Systems (QMS), including electronic systems like Veeva or TrackWise
• Solid understanding of Clinical R&D, global regulations and regulatory submissions
• Experience with leading Regulatory Agency inspections including managing pre-inspection requests, storyboarding, Front Room and Back Room management, and responses to inspection findings (root cause analysis, CAPA, etc.).
• 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

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• 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.

careers.amgen.com

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.