Principal Product Quality Leader

📋 Description

• Provide cross-functional Product Quality leadership for late-stage and commercial biologics
• Develop, implement, and manage quality strategies aligned with product development, manufacturing
• Lead and support activities related to annual product reviews, specifications, comparability
• Author and review GMP and regulatory documentation, including Product Quality-owned sections of
• Evaluate complex process and product-quality data using science- and risk-based approaches to
• Support investigations, change controls, product quality risk assessments, and other lifecycle

🎯 Requirements

• Hold a Doctorate degree with 2+ years of relevant Quality, Operations, Scientific, or Manufacturing
• Preferably hold a B.S. or advanced degree in Chemistry, Biochemistry, Biology, Pharmaceutical
• Bring experience of increasing responsibility within quality, analytical development, process
• Demonstrate 6+ years of experience working in a regulated environment, including direct GMP or
• Have experience authoring or reviewing regulatory documentation such as market applications, INDs
• Demonstrate strong knowledge of cGMP requirements and international regulatory expectations.

🎁 Benefits

• Comprehensive health and welfare benefits for eligible employees and dependents.
• Medical, dental, and vision coverage.
• Retirement and savings plans with employer contributions.
• Life and disability insurance.
• Flexible spending account options.
• Eligibility for a discretionary annual bonus program.