Principal Product Quality Leader

Amgen•Thousand Oaks, CA

About The Position

Amgen’s corporate Product Quality team is seeking a collaborative, motivated leader to provide technical expertise and leadership within a Product Quality Team. The role supports one or more late-stage or commercial biologics products and works across Product Quality, International Distribution Quality, Quality Control, Regulatory, Process Development, Quality Assurance, and other departments. Activities include product filings, program improvements, and investigations involving manufacturing, in-process controls, analytical methods, specifications, stability, reference standards, importation testing, change control, regulatory submissions, and inspections. The Principal Product Quality Leader provides technical expertise and project support to develop, implement, and manage strategies that meet Product Development Team goals. The role owns, authors, and reviews GMP and regulatory documents; executes transactions in relevant GMP systems; and manages product data activities, including comparability assessments, annual product reviews, and product quality risk assessments. The position contributes to initiatives intended to ensure overall product health and supports science- and risk-based evaluation of complex process and product quality data, including development of patient-oriented strategies that address business needs or provide novel solutions.

Requirements

Meet one of the following education and experience combinations: doctorate degree and 2 years of Quality, Operations, Scientific, or Manufacturing experience; master’s degree and 4 years; bachelor’s degree and 6 years; associate’s degree and 10 years; or high school diploma/GED and 12 years.
Demonstrate proficiency in oral and written communication of complex information to Product Quality leadership, peers, and regulatory agencies.
Demonstrate proficiency in cGMP knowledge and international regulatory expectations.
Have strong scientific data management and organization skills with attention to detail.
Have analytical and problem-solving skills.
Work effectively with global, virtual teams.
Show initiative and self-motivation.
Manage multiple priorities, respond quickly to urgent requests, and meet challenging timelines.
Be team-oriented and focused on achieving team goals.

Nice To Haves

B.S. or advanced degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field.
Increasing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment.
6 or more years working in a regulated environment, either in direct GMP work or technical support, with experience working with biologic products.
1 or more years of experience authoring or reviewing market applications, INDs, supplements, or similar regulatory documentation.

Responsibilities

Provide cross-functional quality leadership and support deliverables for late-phase and commercial programs.
Support annual product reviews, specifications, comparability and stability programs, site and method transfers, and product quality impact assessments.
Author Product Quality-owned regulatory filing sections and responses to questions (RTQs).
Evaluate complex process and product quality data using science- and risk-based approaches.
Develop patient-oriented strategies that account for business needs and provide solutions to complex issues.
Own, author, and review GMP and regulatory documents.
Execute transactions in relevant GMP systems.
Manage product data activities, including comparability assessments, annual product reviews, and product quality risk assessments.
Collaborate with Product Quality, International Distribution Quality, Quality Control, Regulatory, Process Development, Quality Assurance, and other departments.

Benefits

Health and welfare plans for staff and eligible dependents.
Retirement and savings plans with company contributions.
Group medical, dental, and vision coverage.
Life and disability insurance.
Flexible spending accounts.
Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.
Stock-based long-term incentives.
Time-off plans.
Flexible work models where possible.
Career development opportunities.