Principal Product Quality Leader
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Job Description
Principal Product Quality Leader guiding quality strategy for Amgen’s late-stage and commercial biologic medicines. Leading GMP documentation, regulatory submissions, investigations, and cross-functional product quality programs.
Responsibilities:
- Provide technical expertise and leadership within a Product Quality Team
- Engage with Product Quality, International Distribution Quality, Quality Control, Regulatory, Process Development, Quality Assurance and other departments
- Support product filings, program improvements, and investigations associated with manufacturing, in-process controls, analytical methods, specifications, stability, reference standards, importation testing, change control, regulatory submissions and inspections
- Support late-stage or commercial biologics products
- Provide technical expertise and project support to Product Quality Teams to develop, implement, and manage strategies aligned with Product Development Team goals
- Own, author, and review GMP and regulatory documents
- Execute transactions in relevant GMP systems
- Manage product data, including comparability assessments, annual product reviews, and product quality risk assessments
- 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, product quality impact assessments, and author Product Quality-owned regulatory filing sections and 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 novel solutions to complex issues
- Interface between research, global development and manufacturing to help ensure molecules become medicines
Requirements:
- Doctorate degree and 2 years of Quality, Operations, Scientific, or Manufacturing experience OR Master’s degree and 4 years of such experience OR Bachelor’s degree and 6 years of such experience OR Associate’s degree and 10 years of such experience OR High school diploma/GED and 12 years of such experience
- Preferred: B.S. or advanced degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field
- Preferred: 6+ years working in a regulated environment, either direct GMP or technical support, with biologic products
- Preferred: 1+ year authoring or reviewing market applications, INDs, supplements, or similar regulatory documentation
- Proficiency in oral and written communication of complex information to Product Quality leadership, peers, and regulatory agencies
- Proficiency in cGMP and international regulatory expectations
- Strong scientific data management and organization skills with attention to detail
- 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, respond quickly to urgent requests, and meet challenging timelines
- Team-oriented focus on achieving team goals
Benefits:
- A comprehensive employee benefits package
- Retirement and Savings Plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models, including remote and hybrid work arrangements, where possible
- Financial plans with opportunities to save towards retirement or other goals
- Work/life balance
- Career development opportunities
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