QA Manager, Qualified Treatment Center Oversight

SUMMARY 

The Quality Assurance Manager, Qualified Treatment Centers will provide QA oversight for onboarding and routine operations at QTCs supporting Genetix’s commercial gene therapies. Additionally, the incumbent in this highly visible role will support building scalable QA processes as Genetix continues to grow, creating energized, efficient, and effective teams internally collaborating with Apheresis Operations, Global Supply Chain (Patient Supply) and Quality Compliance. Day to day responsibilities include establishing and maintaining Quality Agreements with QTCs, primary QA oversight of change controls managing QTC onboarding, QA approval and resolution of QTC-related quality documentation. In addition, support for quality system record management related to collecting and transporting apheresis products and the quality oversight of QTC use of Genetix traceability systems.

This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.

RESPONSIBILITIES

• Ensuring compliance with quality expectations and industry guidelines in the areas of Good Tissue Practices (GTP), Good Manufacturing Practice (GMP) and Good Documentation Practice (GDocP) for apheresis products and Genetix QTCs
• Building relationships with QA partners at QTCs, ensuring quality issues are tracked and resolved in a timely manner and working across the internal Genetix functional network in providing quality oversight of our QTC external partnerships
• Ensuring an appropriate, consistent, and harmonized quality approach is standard across all QTCs through Quality Agreement initiation, review, execution, and maintenance
• Tracking and trending quality system event generation at QTCs, providing periodic updates to management
• Reviewing and approving documents including apheresis collection records, policies and procedures, deviations, investigations, and partner CAPA action plans
• Reviewing and approving internal deviations, CAPA, and Change Control, performing Failure Mode and Effect Analyses, root cause analyses, and CAPA effectiveness check as required
• Developing, monitoring and improving Quality processes which are scalable and sustainable to meet the organization’s growing needs while supporting the development, implementation, and revision of corporate quality systems
• Assisting with internal and external Quality Audits
• Fostering a Quality mindset throughout the company by ensuring consistent, risk-based and innovative thought processes are employed to advise and make decisions)

QUALIFICATIONS 

• BS/BA and a minimum of 7+ years working experience in cell therapy (or applicable) environment. Experience in a hospital setting preferred
• Knowledge of FACT accreditation requirements and their application for collection of apheresis and/or cell therapy lab preferred
• Strong knowledge of GTP regulations and guidance documents
• Experience with quality agreements
• Demonstrated leadership within cross-functional teams with identifying areas of improvement, then participating in the design and delivery of improvements
• Technical understanding of biopharmaceutical production, with experience in cell and gene therapy a plus.