27 days old

Drug Substance Quality Assurance Manager

Thousand Oaks, CA 91360
  • Job Code

Job ID: R-106936
Location: Thousand Oaks, CA, US

The Drug Substance Quality Assurance (QA) Manager will be a member of the Drug Substance Plant QA team and will provide Quality oversight for Drug Substance Manufacturing and supporting Facilities & Engineering operations with primary responsibility for the Thousand Oaks Building 7 drug substance facility, with cell culture operations including both roller bottle and large scale bioreactor processes, and purification processes including column chromatography, depth filtration and ultrafiltration/diafiltration. The QA Manager will be the supervisor for the Plant QA team and will recruit and hire new team members as needed and conduct supervisory duties such as performance management and staff development in line with the Amgen HR program. The individualwill foster the culture of Safety and Quality at ATO. Under general supervision, the QA Manager provides Quality and Compliance oversight for the operational staff during execution of GMP processes, procedures, and use of the Amgen Quality Management System.

The QA Manager may also represent Quality in a cross functional team in the execution of projects necessary to achieve departmental operational excellence goals and will work in a team matrix environment.

Responsibilities include:
  • Maintains the safety of self and others, actively engages with the Amgen EHSS safety program by reporting unsafe conditions if seen and driving improvements
  • Manages a team of QA professionals and prioritizes professional development of direct reports.
  • Performs staff recruitment and selection, training, oversight, and performance evaluations according to Amgen's talent management program.
  • Collaborates with cross functional staff and colleagues to achieve the objectives of the company in a safe and compliant manner
  • Observes GMP operations within a clean room environment and providing appreciative and constructive feedback to staff and managers
  • Reviews and provides Quality approval for electronic batch records, and GMP documentation such as revisions to procedures and GMP documents, work orders, investigation reports, change control records, corrective action / preventive action records, and other GMP records
  • Alerts management of significant quality, compliance, supply and safety risks
  • Participates as a QA team member process during regulatory inspections, third party audits, and internal audits
  • Makes certain the Quality Management System processes are executed in accordance with established procedures
  • May author and own cGMP documents and reports
  • May also perform other duties as assigned
  • May serve as a team member with cross-functional colleagues on internal audits

Basic Qualifications:

Doctorate degree


Master's degree and 3 years of Quality experience


Bachelor's degree and 5 years of Quality experience


Associates degree and 10 years of Quality experience


High school diploma / GED and 12 years of Quality experience

Preferred Qualifications:
  • Excellent interpersonal skills
  • Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners
  • Direct experience driving process improvements. Working knowledge of Lean and Six Sigma methodologies a plus
  • Experience with cGMP production environments. Direct work experience with cGMP processes involved in manufacturing and distribution, QA, analytical laboratory, validation, and process development a plus
  • Experience participating in, managing, and responding to corporate audits/regulatory inspections
  • Experience with TrackWise for supporting investigations and CAPA
  • Experience with Quality Management Systems, including Change Control, Risk Management, Disposition
  • Demonstrated ability to work as both a team player and independently
  • Demonstrated ability with project management, initiating and leading cross-functional teams, leading and managing change
  • Biology, Chemistry, or Engineering degree is desirable

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.



Posted: 2020-10-30 Expires: 2020-11-30

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Drug Substance Quality Assurance Manager

Thousand Oaks, CA 91360

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