Description of RoleThe Manager, Product Quality will provide quality oversight and support for product development and manufacturing activities across the Company portfolio. This role is responsible for ensuring quality considerations are integrated throughout the product lifecycle, from clinical development through commercial readiness.
Reporting to the Executive Director, GMP Quality Assurance, this individual will serve as a key quality partner to Technical Operations, CMC Development, Regulatory Affairs, Clinical Supply Chain, and external manufacturing organizations. The role requires strong technical knowledge, sound judgment, and the ability to effectively manage quality activities in a fast-paced, outsourced development environment.
Key ResponsibilitiesProduct Quality Oversight- Serve as Product Quality lead for assigned development programs.
- Provide quality support for drug substance, drug product, and finished product manufacturing activities.
- Ensure product quality risks are appropriately identified, assessed, and mitigated throughout development.
- Participate in cross-functional project teams and represent Quality in development and manufacturing discussions.
Manufacturing and Technical Operations Support- Review manufacturing documentation, batch records, protocols, reports, and supporting quality documentation.
- Support technology transfers, process scale-up activities, process validation efforts, and manufacturing investigations.
- Partner with Technical Operations and external manufacturing organizations to resolve product quality issues.
- Review analytical results and product quality data to ensure compliance with specifications and requirements.
Investigations, CAPAs, and Change Controls- Review and approve deviations, investigations, CAPAs, and change controls impacting product quality.
- Facilitate risk assessments and root cause analyses.
- Ensure quality events are appropriately investigated and completed within established timelines.
- Monitor quality trends and identify opportunities for proactive improvement.
Regulatory and Inspection Support- Contribute quality input to regulatory filings including INDs, IMPDs, CTAs, BLAs, and NDAs.
- Support responses to regulatory agency questions and requests.
- Participate in inspection readiness activities and support Health Authority inspections and audits.
- Maintain awareness of evolving global regulatory requirements impacting product quality.
Supplier and CMO Management- Support quality oversight of CMOs, CDMOs, laboratories, and other GMP service providers.
- Participate in supplier qualification activities and quality reviews.
- Review quality agreements and support ongoing supplier performance monitoring.
- Collaborate with external partners to ensure compliance with applicable GMP requirements.
Continuous Improvement- Support implementation of quality metrics and monitoring programs.
- Identify opportunities to improve quality processes and increase operational efficiency.
- Promote a culture of quality, compliance, accountability, and continuous improvement.
Qualifications- Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, Engineering, or other scientific discipline required. Advanced degree preferred.
- Minimum 8+ years of quality experience within biotechnology, pharmaceutical, or related regulated industries.
- Experience supporting clinical-stage products required.
- Experience working with external manufacturing organizations required.
- Experience supporting regulatory submissions and inspections preferred.
- Small molecule development experience preferred; biologics experience a plus.
- Strong understanding of cGMP regulations and ICH guidance.
- Working knowledge of pharmaceutical manufacturing, analytical testing, validation, and product lifecycle management.
- Strong problem-solving and risk-management skills.
- Excellent communication and stakeholder management capabilities.
- Ability to thrive in a collaborative, matrixed organization.
Work LocationThe Manager, Product Quailty role is based in the US, with occasional travel.
CompensationThe annual base salary range for this position is $105,000.00 to $150,000.00. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, job knowledge an location.
In addition to base pay, this role is eligible for a discretionary annual bonus. The Company also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.
POSITION: Full-Time, Exempt
