Senior Manager Quality Assurance

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Manager Quality Assurance

What you will do

Let’s do this! Let’s change the world!

The Senior Manager Site Quality Operations (SQO) effectively manages the daily work of direct reports responsible for the quality oversight of sitewide support functions for the Thousand Oaks site, including the Incoming QA function for raw materials and components, and a small group of Quality Management System (QMS) Specialists. The Senior Manager SQO will be responsible for advancing the quality systems, for overseeing incoming material batch record review and release as well as IQA investigations and change controls.

Key responsibilities:

• Ensure that facilities, equipment, materials, organization, processes, procedures and products align with cGMP practices and other applicable regulations.

• Keep up to date with emerging trends and regulatory advances in the areas of incoming raw materials and components.

• Ensure reliable, discerning and timely Quality disposition of raw materials and components, and Amgen transferred shipments of cell bank, drug substance, drug product, and finished drug product.

• Ensure QMS processes are appropriately designed, implemented and managed across the ATO site to ensure they are “fit for purpose” for effective phase appropriate practices in Process Development, Clinical and Commercial functions.

• Ensure QMS site process owners maintain “voice of customer” engagement with process end users along with maintenance and execution of an annual site Quality Process improvement plan describing continuous improvement and productivity initiatives, programs and projects based on execution performance

• Ensure Quality processes in scope are monitored and a process health summary is provided to site leadership on a routine basis.

• Ensure appropriate staff development and training in areas of responsibility.

• Perform review, approval and tracking of cGMP processes, procedures and records, including but not limited to Deviations, CAPAs, change controls, and validation records.

• Champion Continuous Improvement initiatives, programs and projects.

• Ensure that changes that could potentially impact product quality are assessed according to procedures.

• Ensure that deviations from established procedures are investigated and documented.

• Ensure that IQA records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.

• Ensure that GMP functions are periodically audited to assess compliance to cGMP regulations and to identify potential risks.

• Collaborate cross functionally and across the Amgen Enterprise/Network to ensure the Quality Management System processes are implemented, maintained and performed in accordance with established procedures and applicable regulations. Partner with other Amgen sites in the network to ensure consistency and continuous improvement.

• Ensure appropriate escalation of key QMS risks and accomplishments to senior management, through Management Review.

• Lead inspection readiness activities for the areas.

• Participate in Amgen internal/external audits and inspections, potentially interacting directly with regulatory and/or third party auditors.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dyanmic professional we seek is an individual with these qualifications.

Basic Qualifications:

• Doctorate degree and 2 years of quality assurance experience OR

• Master’s degree and 6 years of quality assurance experience OR

• Bachelor’s degree and 8 years of quality assurance experience O