Amgen

Senior Manager - R&D Quality, Compliance and Audit

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Aug 17, 2019
Ref
R-81532
Required Education
High School or equivalent
Position Type
Full time
Amgen's Quality Operations organization serves as a trusted partner to R&D with the responsibility to provide a risk-based Quality Management System (QMS) that is understood and compliant while enabling speed to market and continuous improvement. As a key member of this team, the Senior Manager, Exception Management for Quality, Compliance and Audit will strengthen and advance Amgen's R&D QMS, establish strategy for and lead exception management and own the R&D CAPA System (RDCS) and processes. Promoting a culture of proactive process improvement and change, the Senior Manager will:
  • Function as the Business Process Owner to provide vision, leadership and strategy for QMS and CAPA systems, processes and exception management.
  • Manage and monitor effectiveness of the R&D CAPA System (RDCS) and work with stakeholders to ensure aligned approach to CAPA management and associated regulations.
  • Lead RDCS evolution strategy and advance system integration activities.
  • Define strategies and implement processes and tools for mergers and acquisitions, consistent exception data, trend reporting and root cause analyses.
  • Partner with key stakeholders to ensure aligned approach to CAPA management, provide SME leadership and advice for investigations and root-cause analyses.


Basic Qualifications

Doctorate degree and 2 years of compliance/quality related experience
OR
Master's degree and 6 years of compliance/quality related experience
OR
Bachelor's degree and 8 years of compliance/quality related experience
OR
Associate's degree and 10 years of compliance/quality related experience
OR
High school diploma / GED and 12 years of compliance/quality related experience
AND
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications
  • Advanced degree, such as an MBA or related field
  • 10+ years in Compliance, Quality and/or other relevant areas in the pharmaceutical/ biotech industry
  • 8+ people leadership and management experience
  • Expert knowledge of global regulations impacting R&D activities
  • Experience with Quality Management System oversight and CAPA management
  • Excellent communication, presentation and project management skills
  • Expertise in root cause, impact and risk analyses
  • Strong background in process management


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.