Research Quality Assurance Director
4 days ago
Amgen is a world-renowned biotechnology company seeking an exceptional individual to fill the role of Safety and Medical Quality Lead-Observational Research. As a key member of our Global R&D Quality organization, you will play a vital part in strengthening and enhancing our R&D Quality Management System. This position requires a unique blend of leadership expertise, auditing skills, and knowledge of global regulatory requirements.
**Salary:** $140,000 - $160,000 per annum
About Us
We are a diverse international team responsible for providing Quality oversight on R&D processes and leading activities related to PV regulatory inspections and external audits of the Amgen PV system. Our mission is to serve patients by advancing biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.
Key Responsibilities
Your primary responsibilities will include:
- Leading the pharmacovigilance (GPvP) annual audit plan and preparing and completing audits.
- Investigating and supervising Quality events and supporting partner audits and regulatory inspections.
- Providing Quality input for processes relating to Observational research studies, including the clinical trial risk assessment (CT-RACT).
Required Skills and Qualifications
To succeed in this role, you must have:
- A degree qualification.
- Proven experience in R&D, Operations, and/or Quality experience in the Pharma/Biotech sector.
- Demonstrated leadership expertise in developing teams, coordinating projects or programs, and advising resource allocation.
- A proven track record with auditing, preferably in Good Pharmacovigilance Practice (GPvP) or Good Clinical Practice (GCP) and knowledge of global regulatory requirements.
- Some knowledge of statistical programming used with observational research, such as STATA or SAS.
- Experience and knowledge of requirements for computer systems audits.
- Excellent time management skills and the ability to handle competing priorities.
- Exceptional oral and written communication and writing skills.
Benefits
We offer a comprehensive Total Rewards Plan comprising health, finance, and wealth benefits, work-life balance, and career opportunities. You will also have access to flexible working arrangements, including the option to work fully remotely or flexibly from home with occasional office presence at our Cambridge or Uxbridge next-generation workspace.
Location: United Kingdom, with options to work fully remotely or flexibly from home.
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