Manager QA

The QA Manager will be a member of the Drug Substance Plant QA team and will provide Quality oversight for Drug Substance Manufacturing and support Facilities & Engineering operations. Examples of Drug Substance manufacturing operations include Cell Bank, Cell Culture, and Purification. The individual will contribute to fostering the culture of Safety and Quality at ATO. 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 will lead team of Quality professionals with a strong focus on staff development, ensuring product quality, and building the best team. The QA Manager will also lead cross functional teams in the execution of projects necessary to achieve departmental operational excellence goals, to ensure on-time patient supply of high-quality medicines, and to improve compliance and inspection readiness in operational areas of responsibility.

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
• 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 provides 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 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

OR

Master's degree and 3 years of Quality experience

OR

Bachelor's degree and 5 years of Quality experience

OR

Associate's degree and 10 years of Quality experience

OR

High school diploma / GED and 12 years of Quality experience

AND

Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

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
• Experience with cGMP production environments. Direct work experience with cGMP processes involved in manufacturing and distribution, QA, analytical laboratory, validation, and process development
• 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

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 leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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.

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.