Quality Sr. Manager, Site Lead

Amgen is searching for a Quality Senior Manager Site Lead who will be responsible for Quality and Compliance Oversight of the External Supplier, this includes a contract testing laboratory, contract manufacturing site or a raw material supplier. This Sr. Mgr will have significant responsibility working with supplier quality and manufacturing.

The Senior Manager will report to our Director of Quality Assurance for North American Contract Manufacturing Quality. This role can be filled in multiple locations. These are: our Corporate Campus in Thousand Oaks, CA, or our Rhode Island (West Greenwich) manufacturing facility, or our Cambridge MA research facility, or our Amgen Manufacturing Limited (Puerto Rico) manufacturing facility.

Key responsibilities for this role include:

• Be an integral quality partner of Amgen's cross-functional external supply team that includes: business operations, analytical sciences, process development, supply chain, and external process development
• Be responsible for the preparation of the site for & represent Amgen at product-specific regulatory inspections and/or during Notified Body audits of supplier site | Present on topics during inspections
• Review & approve Master Batch Records | Negotiate & approve quality agreements and deviations, change controls, CAPAs, etc
• Annual Product Review (APR) Data Provider | Manage audit commitments to completion
• Prepare inspection playbooks | Perform Person-in-Plant activities as necessary
• Identify and mitigate risks at supplier sites raise to management as appropriate
• Perform tactical batch disposition activities in support of lot release

Basic Qualifications

Doctorate degree and 2 years of Quality and/or Manufacturing experience

Or

Master's degree and 6 years of Quality and/or Manufacturing experience

Or

Bachelor's degree and 8 years of Quality and/or Manufacturing experience

Or

Associate's degree and 10 years of Quality and/or Manufacturing experience

Or

High school diploma / GED and 12 years of Quality and/or Manufacturing experience

Preferred Qualifications

• Bachelor's of Science degree and 10 + years biotech or pharmaceutical industry experience
• Significant Quality and/or Manufacturing experience at API and Oral Dosage (small molecule DS and DP) manufacturing facilities
• Ability to facilitate and influence senior partners & balance workload and timelines
• Ability to negotiate a strategic position after taking feedback from multiple sources
• Strong project management (PM), problem-solving, and analytical skills & familiarity with PM tools
• Shown ability to lead cross-functional teams, consistently deliver timely and quality results
• A record of collaborating and communicating with others & the ability to balance divergent inputs from various partners while driving issue to resolution
• Ability to operate in a matrixed or team environment with site, functional, and executive leadership
• Familiarity using the "DAI" decision-making process
• Experience with the "variation management" process

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

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.

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.