QA Manager - Site Lead
- Employer
- Amgen
- Location
- Thousand Oaks, CA, US
- Start date
- May 1, 2021
View more
- Discipline
- Manufacturing & Production, Facilities & Site, Quality, Quality Assurance
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Beach, Best Places to Work
Job Details
You've earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you've worked hard to acquire and the passion you already have. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
QA Manager Site Lead
Live
What you will do
Let's do this! Let's change the world!
Job Description
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 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 Amgen's 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-EV's
- 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
Win
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.
Master's degree and 4 years of Quality and/or Manufacturing experience
Or
Bachelor's degree and 6 years of Quality and/or Manufacturing experience
Or
Associate's degree and 8 years of Quality and/or Manufacturing experience
Or
High school diploma / GED and 10 years of Quality and/or Manufacturing experience
Preferred Qualifications
- Bachelor's 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
- 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
Thrive
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 Plan-comprising health, finance and wealth, work/life balance, and career benefits-with compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
Equal 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 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.
Company
We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.
We live the mission.
We win together.
We thrive on continual challenge.
Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.
At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.
Connect with us to explore how you can Win, Live, and Thrive at Amgen.
- Website
- http://careers.amgen.com/
- Phone
- 805-447-1000
- Location
-
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
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