Quality Sr Manager
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.
Quality Sr. ManagerLive
What you will do
Lets do this! Lets change the world!
Amgen is searching for a Quality Senior Manager site lead who will be responsible for Quality and Compliance oversight of a contract manufacturing site. This Quality Senior Manager will have significant responsibility working with supplier quality and manufacturing.
The Quality Senior Manager will report into Quality Assurance for North American Contract Manufacturing Quality. This role can be filled in multiple locations in the United States.Key responsibilities for this role include:
Being an integral quality partner of Amgens cross-functional external supply team that includes: Business operations, analytical sciences, process development, supply chain, and external process development
Review and approve master batch records, deviations, change controls, CAPAs, and CAPA-EVs
Provide data for Annual Product Review (APR)
Manage audit commitments to completion
Represent Amgen at product-specific regulatory inspections and/or during Notified Body audits of supplier site
Prepare topics to be presented during inspections
Prepare inspection playbooks
Identify and mitigate risks at supplier site and raise to management as appropriate
Perform tactical batch disposition activities in support of lot release
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The vital attribute professional we seek will have these qualifications.
Doctorate degree and 2 years of Quality and/or Manufacturing experience
Masters degree and 6 years of Quality and/or Manufacturing experience
Bachelors degree and 8 years of Quality and/or Manufacturing experience
Associates degree and 10 years of Quality and/or Manufacturing experience
High school diploma / GED and 12 years of Quality and/or Manufacturing experiencePreferred Qualifications
Bachelors of Science degree
10 + years biotech or pharmaceutical industry experience
Significant Quality and/or Manufacturing experience at small and/or large molecule DS, DP or FDP 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
What you can expect of us
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.
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
#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.