Quality Assurance Manager - External Site Lead
HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Quality Assurance ManagerLive
What you will do
Lets do this. Lets change the world.
The Quality Assurance Manager will be responsible for quality and compliance oversight of external partners that are part of Amgens network of GMP service providers.Key Responsibilities
Serve as the Quality Assurance point of contact for Amgen external partners/sites
Facilitate and support the business relationship between internal Amgen sites and external partners; act as point of contact for customer concerns and drive successful resolution of issues
Ensure external site performance is acceptable and aligned to Amgen business needs; implement recovery plans or mitigation actions when vital (pertains to timely delivery, adherence to cycle times, and ensure contractual obligations are being fulfilled as defined in the quality agreements, statements of work, etc.)
Review and/or approve executed production batch records, deviations, master batch records, change controls, and audit/inspection responses, and other quality records, etc.
Understand and interpret applicable GMP regulations pertaining to manufacturing and testing activities
Provide quality oversight of the manufacturing, testing, and release of Amgen materials
Author QA periodic monitoring reports summarizing external site performance; identify quality issues/risks and implement improvement plans as needed
Monitor and communicate site performance in terms of quality metrics through periodic monitoring reports, and or business/operating reviews
Author inspection playbooks with external site highlighting key risks/gaps and drive readiness activities
Represent Amgen in regulatory inspections and/or during notified body audits of external site
Support regulatory activities and requests for information as needed for filings, marketing applications, etc.
Identify risks or roadblocks to management; raise critical issues in a timely manner
Drive decision-making using DAI principles
Drive continuous improvements and Amgen first mentality
What we expect of you
We are all different, yet we all use our outstanding contributions to serve patients. The vital attribute professional we seek will have these qualifications.Doctorate degree
Masters degree & 3 years of quality and manufacturing experience in biotech or pharmaceutical industryOr
Bachelors degree & 5 years of quality and manufacturing experience in biotech or pharmaceutical industryOr
Associates degree & 10 years of quality and manufacturing experience in biotech or pharmaceutical industryOr
High school diploma / GED & 12 years of quality and manufacturing experience in biotech or pharmaceutical industryPreferred Qualifications:
Experience with Contract Labs (CL), Quality Control Labs and Contract Management (CMO) QA oversight
Ability to travel +/- 10% of time to domestic and international Amgen/external sites
Some of the vast rewards of working here
As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
Objects in your future are closer than they appear.
Join us. careers.amgen.com
#operations21Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Join UsIf 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.