Amgen Director Product Quality in Thousand Oaks, California
The Product Quality Director is the champion for a product team as the Product Quality Leader (referred to as PQL), providing technical expertise, strategic and project leadership to the Product Quality (PQ) organization. The PQL has responsibility for working with PQ staff and executive leadership, International Quality, Quality Control, Contract Manufacturing Quality, Regulatory, Process Development, Quality Assurance, and other functional areas 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. The PQL has responsibility for driving change to implement operationally efficient processes and corporate alignment across international sites. As a leader in Product Quality, the successful candidate is expected to have experience, knowledge and understanding of large and/or small molecule development and commercial lifecycle maintenance, product stability programs, regulatory filings, risk assessment, and Amgen Quality Management Systems.
Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure that our molecules become medicines. Many of the technologies we’re employing are not only new to Amgen but are new to the industry as a whole. Help us to pave new roads for helping patients.
This role is directly responsible for the product quality and related activities (e.g., comparability, specifications, stability, annual product review) in support of the Product Development Team (PDT). The PQL provides scientific oversight for the product quality of pivotal and/or commercial product(s) including timely product data review, ownership of GMP documents and regulatory filing sections, execution of transactions in relevant GMP system (EDMQ, change control, etc), and support for regulatory audits and responses to questions. The individual is directly responsible to lead a Product Quality Team (PQT), including oversight of the product stability programs, providing indirect staff management and guidance to members of the PQT.
Key Responsibilities include:
Provide effective, cross-functional quality leadership, and manage multiple, complex long-term PDT deliverables for late phase and commercial programs, including actions required for the PQT/APR; specification, comparability, and stability programs; site and method transfers; product quality impact statements for NCs; and PQ owned regulatory filing sections and RTQs
Provide expertise in science and risk-based evaluation of complex process and product quality data, including ability to develop patient-oriented strategies that account for business needs and/or provide novel solutions to complex issues
Demonstrate proficiency in oral and written communication of complex information to Amgen leadership, peers and regulatory agencies including communications associated with inspectional activities
Demonstrate proficiency in knowledge of cGMP and international regulatory expectations
Understand and respond to the impact of emerging scientific/technical trends and their implications for Amgen
Actively mentor new and existing team members to develop Product Quality core skills
Doctorate Degree & 4 years of directly related experience, OR
Master's Degree & 8 years of Quality, Operations, Scientific, or Manufacturing experience, OR
Bachelor's Degree & 10 years of Quality, Operations, Scientific, or Manufacturing experience, AND
4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
Advanced degree in chemistry, biochemistry, biology, or a related biotechnology sciences field
Expertise in the areas of protein and small molecule analysis and industry regulations
8+ years of pharmaceutical experience with increasing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment experience
6+ years working in a regulated environment (direct GMP)
5+ years managing staff with increasing responsibilities and larger groups
2+ years experience as a PQL, technical expert or product champion
1+ years of experience with authoring or review of regulatory filing or similar regulatory documentation.
1+ years of experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances
Experience in Project Management in support of product development
Knowledge of protein and small molecule quality, compliance and regulatory requirements
Knowledge of analytical techniques used for protein molecule product quality control
Understanding of drug substance and drug product development and manufacturing
Strong leadership and management skills
General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture and testing of pharmaceuticals
Previous experience working on a cross-functional team in a matrix environment
Excellent written and verbal communication skills, including facilitation and presentation skills
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.