Senior Manager / Associate Director, Quality Operations

Responsibilities

• Provide Quality oversight for GxP Partners, Suppliers & service providers. (CDMOs, CROs, central laboratories, apheresis centers, logistics providers, and clinical sites.)
  • Lead the qualification, onboarding, performance monitoring, and lifecycle management activities of GxP suppliers and services providers.
  • Accountable for Quality Agreements & risk-based oversight plans for GxP Partners, Suppliers and service providers.
  • Lead supplier audits, supplier Quality Business Reviews (QBRs)
  • Ensure effective management of supplier deviations, investigations, CAPAs, change controls.
• Provide quality oversight across the entire cell therapy journey, from patient collection through product administration, supporting clinical development, pivotal studies, and commercial readiness.
  • Provide quality oversight of outsourced manufacturing operations supporting clinical and commercial readiness activities.
  • Lead batch disposition activities and quality system elements including deviations and change controls.
  • Ensure product operations activities comply with applicable GMP, ICH, regulatory requirements.
  • Partner cross-functionally with CMC, Product Operations, Clinical Operations, Regulatory Affairs teams to support comparability, process validation, and product lifecycle activities.
  • Ensure timely escalation and resolution of significant quality and patient safety issues while promoting a proactive culture of quality and continuous improvement.
• Provide quality oversight for clinical trial execution and governance of outsourced clinical activities to ensure compliance with GCP and applicable regulatory requirements.
  • Support CRO governance and quality management programs.
  • Ensure appropriate escalation and management of critical quality and patient safety issues.
  • Support inspection readiness across clinical operations by leading audit programs, assessing quality risks, and supporting regulatory authority inspections.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Engineering, or related field; advanced degree preferred.
• 8-10+ years of progressive quality leadership experience in cell therapy, biotechnology, or biologics, and at least 5 years in cell therapy, including leadership responsibilities in GMP and/or GCP environments.
• In-depth understanding of GxP quality systems, including GMP, GCP, ICH, FDA regulations, and global regulatory requirements.
• Demonstrated expertise in cell therapy or ATMP manufacturing.
• Demonstrated success leading QA operations, with compliance oversight of external manufacturing and technical operations.
• Demonstrated experience overseeing CDMOs, CROs, CTLs, logistics providers, & GxP suppliers.
• Experience supporting regulatory inspections and health authority interactions, with a demonstrated ability to maintain inspection readiness.
• Excellent leadership, communication, and cross-functional collaboration skills, with the ability to influence internal and external stakeholders.
• Demonstrated ability to prioritize competing demands, solve complex quality issues, and thrive in a fast-paced, evolving environment.
• Hightly organized, team-oriented, and able to work with minimal supervision while maintaining a positive attitude.

Preferred Qualifications

• Certification in auditing (e.g., ASQ Certified Quality auditor, or equivalent) or formal FMP/GCP auditing experience.