QA Mgr - 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.Live
What you will do
Lets do this. Lets change the world.
Amgen is searching for a Quality Manager site lead who will be responsible for Quality and Compliance oversight of contract manufacturing sites. This Quality Manager will have significant responsibility working with supplier quality and manufacturing. The Quality Manager will also provide support to Quality Senior Manager site leads.
The Quality 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
Some travel required
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.
Masters degree and 3 years of Quality and/or Manufacturing experience
Bachelors degree and 5 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 experience
Bachelors of Science degree
8 + years biotech or pharmaceutical industry experience
Significant Quality and/or Manufacturing experience at small and/or large molecule DS, DP or FDP manufacturing facilities. Experience with synthetics/small molecules a plus.
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
Some of the vast rewards of working here
As we work to develop treatments that take care of others, we also 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 improve 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
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 demonstrates its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.careers.amgen.com
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.
We will ensure that individuals with disabilities are provided 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 accommodation.Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.