QA Manager, Qualified Treatment Center Oversight

About Genetix Biotherapeutics

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.

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.

Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.  All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.