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
Doctorate degree and 4 years of Quality or Operations experience
Master’s degree and 8 years of Quality or Operations experience
Bachelor’s degree and 10 years of Quality or Operations experience
4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
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.