Principal Product Quality Leader

About the Role

This is a senior quality leadership opportunity supporting late-stage and commercial biologics programs in a highly regulated, science-driven environment. The role focuses on protecting product quality and patient safety while enabling successful development, commercialization, and lifecycle management. You will work with global and virtual teams to transform complex quality challenges into practical, patient-focused solutions.

Responsibilities

• Provide cross-functional Product Quality leadership for late-stage and commercial biologics programs, supporting strategic priorities and program deliverables.
• Develop, implement, and manage quality strategies aligned with product development, manufacturing, regulatory, and patient-safety objectives.
• Lead and support activities related to annual product reviews, specifications, comparability assessments, stability programs, site and analytical method transfers, and product-quality impact assessments.
• Author and review GMP and regulatory documentation, including Product Quality-owned sections of regulatory submissions and responses to regulatory questions.
• Evaluate complex process and product-quality data using science- and risk-based approaches to identify issues, assess potential impacts, and develop appropriate solutions.
• Support investigations, change controls, product quality risk assessments, and other lifecycle activities associated with biologic products.
• Execute and manage transactions within relevant GMP systems while maintaining accurate product data and documentation.
• Partner with various stakeholders to deliver program objectives.
• Provide technical expertise on complex quality matters, balancing patient needs, scientific evidence, regulatory expectations, and business considerations.
• Communicate complex technical and quality information effectively to senior leadership, internal stakeholders, and regulatory agencies.
• Contribute to continuous improvement initiatives to strengthen product health, quality systems, and operational effectiveness.
• Manage multiple priorities, urgent requests, and challenging timelines while maintaining high standards of quality, compliance, and scientific rigor.

Requirements

• Hold a Doctorate degree with 2+ years, a Master’s degree with 4+ years, a Bachelor’s degree with 6+ years, an Associate’s degree with 10+ years, or a high school diploma/GED with 12+ years of relevant experience in Quality, Operations, Scientific, or Manufacturing.
• Preferably hold a B.S. or advanced degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or a related scientific discipline.
• Bring experience of increasing responsibility within quality, analytical development, process development, pharmaceutics, regulatory, manufacturing, or a related pharmaceutical environment.
• Demonstrate 6+ years of experience working in a regulated environment, including direct GMP or technical-support experience with biologic products.
• Have experience authoring or reviewing regulatory documentation such as market applications, INDs, supplements, or comparable submissions.
• Demonstrate strong knowledge of cGMP requirements and international regulatory expectations.
• Possess strong scientific data management, organization, documentation, and analytical skills with exceptional attention to detail.
• Demonstrate the ability to assess complex scientific and product-quality information and convert it into clear, risk-based recommendations.
• Bring strong oral and written communication skills, particularly when presenting complex information to diverse audiences.
• Be comfortable working effectively with global, geographically distributed, and virtual teams.
• Demonstrate strong problem-solving, critical-thinking, and decision-making abilities.
• Be highly self-motivated, proactive, and capable of working independently while maintaining strong collaboration with stakeholders.
• Successfully manage multiple priorities, shifting demands, urgent issues, and challenging deadlines.
• Demonstrate a team-oriented mindset with a strong focus on shared goals, quality, compliance, and patient outcomes.

Benefits

• Competitive annual base salary range of approximately $138,639 to $187,571 USD.
• Comprehensive health and welfare benefits, including 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.
• Stock-based long-term incentive opportunities.
• Award-winning paid time-off programs.
• Flexible work models, including remote and hybrid arrangements.
• Opportunities for professional development and career growth.
• Exposure to innovative biologics programs and emerging technologies.
• Contribution to initiatives supporting the development and delivery of medicines for patients with serious illnesses.
• Inclusive workplace valuing collaboration, scientific excellence, and continuous innovation.

Location: Remote in the United States, Ireland, and Puerto Rico, subject to applicable work-location requirements.