12 days old

Global Compliance Director - GCP Strategy

Amgen
Thousand Oaks, CA 91360
  • Job Code
    124662369
Amgen

Job ID: R-105430
Location: Thousand Oaks, CA, US 91360
Additional Location: US - Rhode Island - West Greenwich, United Kingdom - Cambridge, US - Florida - Tampa, United Kingdom - Uxbridge

GLP/GCP Compliance Director

Reporting to the VP Quality Operations, the GLP/GCP Director will lead and manage the GLP & GCP Compliance team and provide guidance to Amgen senior stakeholders to identify/resolve compliance issues and mitigate compliance risk. The GCP/GLP Director is responsible for leading all aspects of quality and compliance across the GLP/GCP space and ensures global research and clinical development activities meet quality standards and are in compliance with applicable regulations and requirements, while leading the team.

Accountabilities
  • Lead and coordinate GLP/GCP compliance risk assessments, including development of annual audit program
  • Provide expert compliance advice on GLP/GCP programs, initiatives and activities to help manage and mitigate risk
  • Serve as GLP/GCP Compliance representative on senior compliance/ quality oversight bodies
  • Facilitate timely and appropriate remediation of GLP/GCP audit and inspection findings
  • Facilitate and review responses to regulatory authority GLP/GCP inspections
  • Report and escalate significant compliance issues to Quality management and senior stakeholders
  • Review and analyze audit, inspection and CAPA data to identify compliance trends and areas of exposure
  • Develop and deliver periodic compliance reports, including relevant metrics, to key stakeholders and management
  • Assess impact of changes in new regulations and the external environment and advise stakeholders accordingly
  • Ensure proactive identification, escalation, management and remediation of compliance issues relating to Amgen processes, programs, and external relationships


Key Capabilities

  • Organizational expert within defined subject areas


  • Contributes to the development of new principles and concepts within a regulatory field


  • Understands impact of emerging regulatory trends and their implications for Amgen


  • Analyzes and forecasts regulatory trends


  • Develops complex solutions to problems through in-depth analysis, coordination and negotiation with key decision makers


  • Adapts and integrates own experience with Amgen-wide strategy


  • Develops innovative solutions to problems without precedent


  • Contributes to strategic decisions affecting GLP/GCP compliance


  • Aligns operational plan with functional strategy and approach


  • Accomplishes results through the management of a team of professional employees and/or managers and other leaders


  • Acts as an advisor to subordinate staff members



Qualifications

Doctorate Degree and 4 years of Quality experience

OR

Master's Degree and 8 years of Quality experience

OR

Bachelor's Degree and 10 years of Quality experience

AND

4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Experience

Required:

Minimum of 10 years in biopharmaceutical industry

Minimum 5 years in GCP compliance

Preferred:

Experience supporting regulatory authority inspections of research and development activities

Participation in process improvement initiatives

Prior experience in global role

Minimum 4 years' experience managing compliance/QA professionals

Knowledge
  • Thorough knowledge and application of international requirements of GCP and GLP
  • Understanding of drug development cycle and processes
  • Audit/Compliance program design and audit methodology


Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, or disability status.



PI124662369
Posted: 2020-10-09 Expires: 2020-11-09

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Global Compliance Director - GCP Strategy

Amgen
Thousand Oaks, CA 91360

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