Director Quality Assurance

1. Leads and directs all aspects of Quality Assurance for Amgen Thousand Oaks Drug Product (DP) Manufacturing facilities, primarily Bldg 20 (aseptic manufacturing and inspection) and Bldg 31 (packaging, warehousing and distribution)
2. Ensures that pharmaceutical products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP) and other applicable regulations and specifications
3. Implements the Amgen Quality Management System across the responsible buildings and processes in accordance with corporate standards
4. Periodically reviews performance metrics to identify, report, address and correct all quality risks
5. Leads the QA Team for DP Manufacturing, and acts as building/process Quality representative where required
6. Ensures that there is an adequate number of qualified personnel who possess an adequate combination of education, experience and training provided to perform assigned QA functions in accordance with requirements and specifications
7. Ensures Quality oversight of pharmaceutical product, production records, documents and procedures
8. Serves as the QA representative to regulatory authorities, Amgen Corporate auditors, and 3rd party auditors for drug product production
9. Alerts senior management of significant quality, compliance, supply and safety risks
10. Works in partnership with DP Manufacturing leadership to assure quality of Amgen products complies with applicable regulations and specifications
11. Supports Continual Improvement initiatives, programs and projects of the Quality System

12. Collaborates as a full member of the ATO Site Quality Leadership Team to ensure holistic management of Quality across the site

Basic Requirements:

Doctorate degree and 4 years of [Job Code's Discipline and/or Sub-Discipline] experience
OR
Master's degree and 8 years of [Job Code's Discipline and/or Sub-Discipline] experience
OR
Bachelor's degree and 10 years of [Job Code's Discipline and/or Sub-Discipline] experience
AND
4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

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.