Principal Product Quality Leader

About the role

Join Amgen’s corporate Product Quality team as a Principal Product Quality Leader. In this role, you will provide technical expertise and leadership within a Product Quality Team, engaging with various departments on activities such as product filings, program improvements, and investigations related to product manufacturing, in-process controls, analytical methods, specifications, stability, reference standards, importation testing, change control, regulatory submissions, and inspections.

You will support one or more of Amgen's late-stage or commercial biologics products, offering technical expertise and project support to develop, implement, and manage strategies that meet Product Development Team goals. Your responsibilities will include ownership, authoring, and review of GMP and regulatory documents, execution of transactions in relevant GMP systems, and product data management, including comparability assessments, annual product reviews, and product quality risk assessments.

Responsibilities

• Provide effective, cross-functional quality leadership and support program deliverables for late-phase and commercial programs, including annual product reviews, specifications, comparability, and stability programs; site and method transfers; product quality impact assessments; and author PQ-owned regulatory filing sections and RTQs.
• Support science and risk-based evaluation of complex process and product quality data, developing patient-oriented strategies that account for business needs and provide novel solutions to complex issues.
• Ownership, authoring, and review of GMP and regulatory documents.
• Execution of transactions in relevant GMP systems and product data management, including comparability assessments, annual product reviews, and product quality risk assessments.

Qualifications

Basic Qualifications

• Doctorate degree and 2 years of Quality, Operations, Scientific, or Manufacturing experience
• OR Master’s degree and 4 years of Quality, Operations, Scientific, or Manufacturing experience
• OR Bachelor’s degree and 6 years of Quality, Operations, Scientific, or Manufacturing experience
• OR Associate’s degree and 10 years of Quality, Operations, Scientific, or Manufacturing experience
• OR High school diploma / GED and 12 years of Quality, Operations, Scientific, or Manufacturing experience

Preferred Qualifications

• B.S. or advanced degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field with experience in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment.
• 6+ years working in a regulated environment (either direct GMP or technical support) with experience working with biologic products.
• 1+ year experience with authoring or review of market applications, IND, supplements, or similar regulatory documentation.

Skills

Functional Skills

• Proficiency in oral and written communication of complex information to Product Quality leadership, peers, and regulatory agencies.
• Knowledge of cGMP and international regulatory expectations.
• Strong scientific data management and organization skills with attention to detail.

Soft Skills

• Analytical and problem-solving skills.
• Ability to work effectively with global, virtual teams.
• High degree of initiative and self-motivation.
• Ability to manage multiple priorities successfully, react quickly to address urgent requests, and meet challenging timelines.
• Team-oriented, with a focus on achieving team goals.

Pay

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted on the careers site. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote and hybrid work arrangements, where possible.