Amgen Director Quality Control in Thousand Oaks, California

Amgen is seeking a Director of Quality at its corporate campus in Thousand Oaks, CA to join the Quality Control Unit. The Director will report to the Executive Director of Quality for Clinical and Commercial Operations.

Primary focus as the Director Quality Control (QC) is to successfully provide oversight of analytical testing in support of bulk manufacturing and fill/finish operations across a diverse release and stability testing portfolio.

Key responsibilities for the Director of Quality include:

Ensure investigations are conducted in a timely manner with thorough Root Cause Analysis and effective CAPAs

Partner with other functional area leads across Process Development, Attributes Sciences, QC network and Product Quality to effectively execute method transfers and validations

Represent QC organization in related Network teams and company-wide initiatives

Ensure compliance with procedures relating to area of responsibilities

Participate in regulatory inspections and site audits; lead QC activities during regulatory inspections, including inspection management and response strategies

Basic Qualifications

Doctorate degree and 4 years of Quality or Operations experience

OR

Master's degree and 8 years of Quality or Operations experience

OR

Bachelor's degree and 10 years of Quality or Operations experience

AND

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

Preferred Qualifications

15 + years' pharmaceutical industry experience in Quality, Manufacturing, Engineering or Process Development

Able to facilitate and influence clients and partners

Able to successfully manage workload to timelines

Familiarity with basic project management tools and lean

Ability to interpret regulations

Expert knowledge of quality processes and Quality Control operations

Strong working knowledge of cGMPs and regulatory expectations related to QC roles and responsibilities

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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.