Principal Product Quality Leader in Abbeyville, Colorado at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Principal Product Quality Leader based in the United States.

This is a senior quality leadership opportunity supporting late-stage and commercial biologics programs in a highly regulated, science-driven environment.
You will provide technical and strategic leadership across Product Quality, Manufacturing, Quality Control, Regulatory, Process Development, and other global functions.
The role focuses on protecting product quality and patient safety while enabling successful development, commercialization, and lifecycle management.
You will evaluate complex scientific and product-quality data, develop risk-based strategies, and help resolve challenging quality issues.
Your work will influence regulatory submissions, product health initiatives, investigations, stability programs, specifications, and process or method transfers.
The position offers significant exposure to innovative technologies at the intersection of research, global development, and manufacturing.
Working with global and virtual teams, you will help transform complex quality challenges into practical, patient-focused solutions.

• 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 Product Quality, International Distribution Quality, Quality Control, Regulatory, Process Development, Quality Assurance, Manufacturing, and other stakeholders to deliver program objectives.
• Provide technical expertise and sound judgment 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 designed 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.

• Hold a Doctorate degree with 2+ years of relevant Quality, Operations, Scientific, or Manufacturing experience; or a Master’s degree with 4+ years; or a Bachelor’s degree with 6+ years; or an Associate’s degree with 10+ years; or a high school diploma/GED with 12+ years of relevant experience.
• 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 leadership, peers, cross-functional teams, and regulatory authorities.
• 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.

• Competitive annual base salary range of approximately $138,639 to $187,571 USD, with actual compensation determined by relevant skills, experience, qualifications, and other factors.
• 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.
• Stock-based long-term incentive opportunities, subject to eligibility.
• Award-winning paid time-off programs.
• Flexible work models, including remote and hybrid arrangements where applicable.
• Opportunities for professional development and career growth in a collaborative, science-based environment.
• Exposure to innovative biologics programs and emerging technologies across research, development, manufacturing, and quality.
• The opportunity to contribute to initiatives that support the development and delivery of medicines for patients with serious illnesses.
• An inclusive workplace that values collaboration, scientific excellence, diverse perspectives, and continuous innovation.
• The position is available remotely in the United States, Ireland, and Puerto Rico, subject to applicable work-location requirements.