Principal Product Quality Leader

Thousand Oaks, CA, US
Oct 06, 2020
Required Education
Bachelors Degree
Position Type
Full time
The Principal Product Quality Leader will provide technical expertise and project leadership to the Product Quality organization. As a product expert in Quality, the Principal Product Quality Leader (referred to as a Product Quality Principal / PQP) has responsibility for working with PQLs, International Quality, Quality Control, Regulatory, Process Development, Quality Assurance, and other departments on the resolution of issues associated with process/manufacturing, in-process controls, analytical methods, specifications, reference standards, importation testing, investigations, change control, regulatory submissions and inspections.

This role will support one or more of Amgen's products. The individual will provide technical expertise and project leadership to the relevant Product Quality Team(s) to develop, implement, and manage strategy for Quality to meet the GOT and product goals for Amgen synthetic products. The individual will be directly responsible for Product Quality related tasks in support of the Product Quality Teams, including ownership, authoring and review of documents, and execution of transactions in relevant GMP systems (change control, etc.). In addition to these responsibilities, the candidate will be expected to play a role in supporting product quality issues and initiatives intended to ensure the overall product health.

Basic Qualifications:

Doctorate degree & 2 years of Quality experience
Master's degree & 6 years of Quality experience
Bachelor's degree & 8 years of Quality experience
Associate's degree & 10 years of Quality experience
High school diploma / GED & 12 years of Quality experience

Preferred Qualifications:

B.S. in biochemistry, biology, or a related protein sciences/biotechnology field and 8+ years of biopharmaceutical experience with increasing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment, OR an Advanced degree in chemistry biochemistry, chemical engineering, or biology and 4+ years of biopharmaceutical experience with increasing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment experience
6+ years working in a regulated environment (either direct GMP or technical support)
1+ year experience with authoring or review of synthetic license applications, IND, supplements or similar regulatory documentation
1+ year experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances
Experience in Project Management in support of biopharmaceutical development
Familiarity with compliance and regulatory requirements of the FDA as well as international regulatory agencies
Experience in direct interaction with regulatory agencies during inspections and/or meetings
Knowledge of analytical techniques used for synthetic product quality control
Understanding of biopharmaceutical bulk and drug product development and manufacturing
General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture and testing of biopharmaceuticals
Experience working on a cross-functional team in a matrix environment
Excellent written and verbal communication skills, including facilitation and presentation skills

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.