Quality Assurance Manager (QTC)

Kelly Science is seeking a Quality Assurance Manager to join a growing team in Boston, MA for a long term contract.

Pay: $62-72/hour depending on experience

Shift: Monday-Friday 8am-5pm

Employment Type: Full Time; 12 month contract

Work Model: Hybrid- 3 days on-site 2 days WFH

Summary:

The Quality Assurance Manager will oversee quality at the companies Qualified Treatment Centers (QTCs) for commercial gene therapies. This key role involves building scalable QA processes to support company growth, working closely with Apheresis Operations, Global Supply Chain, and Quality Compliance. Key responsibilities include managing Quality Agreements with QTCs, overseeing change controls for QTC onboarding, and approving QTC-related quality documentation. This role also supports quality system record management for apheresis product collection and transport, plus overseeing QTC use of the companies traceability systems.

Job duties include:

• Ensure GTP, GMP, and GDocP compliance for apheresis products and the companies QTCs.
• Build relationships with QTC QA partners, track quality issues, and collaborate with internal teams for resolution.
• Standardize quality approaches across all QTCs through Quality Agreements.
• Track and trend quality system events at QTCs, providing management updates.
• Review and approve documents (e.g., collection records, deviations, CAPAs).
• Review/approve internal deviations, CAPAs, and Change Controls; perform root cause analysis as needed.
• Develop and improve scalable and sustainable quality processes.
• Promote a risk-based and innovative quality mindset throughout the company.

Qualifications:

• Bachelors degree in a scientific related field
• 7 years of experience working within a cell therapy environment (hospital setting preferred)
• Strong knowledge of FACT accreditation requirements and its applications for collection of apheresis and or cell therapy labs, GTP regulations and guidance documents and quality agreements strongly preferred.

Interested? Please apply today for immediate consideration!