Amgen

QA Mgr - Site Lead

Employer
Amgen
Location
Thousand Oaks, CA
Posted
Jun 07, 2021
Ref
R-117588
Required Education
High School or equivalent
Position Type
Contract

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.

QA Manager - Site Lead

Live

What you will do

Lets do this! Lets 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 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

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.

Masters degree and 4 years of Quality and/or Manufacturing experience

Or

Bachelors degree and 6 years of Quality and/or Manufacturing experience

Or

Associates 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
  • 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

  • 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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

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.