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. Manager 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:**
+ Being 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
+ Represent Amgen at product-specific regulatory inspections and/or during Notified Body audits of supplier site
+ Present on topics during inspections
+ Review and approve Master Batch Records; Negotiate and 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 and raise to management as appropriate
+ Perform tactical batch disposition activities in support of lot release
+ Ability to travel +/- 20% to external sites
Doctorate degree and 2 years of Quality and/or Manufacturing experience
Master’s degree and 6 years of Quality and/or Manufacturing experience
Bachelor’s degree and 8 years of Quality and/or Manufacturing experience
Associate’s degree and 10 years of Quality and/or Manufacturing experience
High school diploma / GED and 12 years of Quality and/or Manufacturing experience
+ Bachelor’s of Science degree
+ 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 and 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 and 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 and 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._**
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.