Manager, Quality Assurance Operations

• Provide Quality oversight of external partners across the supply chain—including CDMOs and cryopreservation sites—serving as the primary QA point of contact
• Lead batch disposition activities to ensure timely, compliant, and right first time product release
• Review and approve master batch records, QC test methods, validation protocols/reports, specifications, and associated documentation
• Author, review, and revise SOPs and controlled documents as needed
• Initiate, review, and approve investigations, root cause analyses, risk assessments, change controls, and CAPAs
• Participate as a cross functional team member in process validation, analytical validation, technology transfer, and manufacturing readiness activities
• Collaborate with CMC and GxP functional groups to provide QA guidance and support across development and manufacturing operations
• Support internal and external audit programs, training initiatives, and inspection readiness activities
• Develop, track, and report Quality metrics and KPIs for both internal processes and external partners to drive continuous improvement and ensure accountability
• Work independently while fostering strong, collaborative relationships across internal teams and external partners
• Champion a culture of quality, transparency, and continuous improvement
• Other related duties, as assigned

• Bachelor’s degree required, preferably in biomedical sciences, regulatory affairs, clinical research, nursing, or related health sciences
• Cell and gene therapy experience required
• autologous cell therapy experience strongly preferred
• Minimum of 5+ years of relevant experience in Quality Assurance, Quality Operations, Quality Compliance and GMP manufacturing
• Minimum of 3 years providing Quality oversight of CDMOs within a GMP manufacturing environment or global pharmaceutical setting
• Extensive knowledge of GMP, GCP, ICH guidelines, and FDA biologics regulations
• Knowledge of federal research regulations and guidance, including 21 CFR Parts 11, 50, 54, 56, 312, 812
• 45 CFR 46
• ICH GxP guidance
• and relevant EU/UK regulations
• Demonstrated proficiency with electronic Quality Management Systems (eQMS)
• Excellent writing and presentation skills, with the ability to clearly interpret and communicate regulatory and compliance requirements
• Strong interpersonal, communication, and leadership skills with the ability to influence and build effective professional relationships
• Attention to detail and the ability to provide clear, pragmatic, risk-based QA guidance
• Highly organized, self-directed, and committed to continuous professional development
• Ability to thrive in a dynamic, fast-paced environment with evolving priorities

Experience supporting programs transitioning from early phase to late phase and commercial readiness is desirable

health and retirement, PTO, and stock option plans