QA Manager, Qualified Treatment Center Oversight

Genetix Biotherapeutics•Somerville, MA

3d•$115,000 - $140,000•Hybrid

About The Position

At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values: Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care. 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.

Requirements

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.

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)