QA Manager, Training (LMS)

SUMMARY

The QA Manager, Training (LMS) will be responsible for the oversight, administration, and continuous improvement of the company’s electronic Learning Management System (Compliance Wire) to ensure compliance with FDA, EMA, ICH, and other global regulatory expectations for Cell and Gene Therapy (CGT) operations. This role ensures that training programs are effectively designed, executed, and documented to support a state of control across GxP functions, including Manufacturing, Quality, Supply Chain, MSAT, and Clinical Operations.

The ideal candidate has strong experience with Compliance Wire, GxP training programs, and QA systems within advanced therapies, including CGT, autologous/allogeneic platforms, or viral vector manufacturing environments.

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

RESPONSIBILITIES

• Serve as the system owner for the GxP Learning Management System (Compliance Wire), ensuring validated state, data integrity, and compliance with 21 CFR Part 11 and EU Annex 11 requirements.
• Develop, implement, and maintain training processes, procedures, and work instructions aligned with CGT regulatory requirements.
• Ensure that training curricula, assignments, and qualification requirements are current, risk-based, and aligned with job roles.
• Oversee training content lifecycle, including creation, review, approval, periodic review, and archival in Compliance Wire.
• Monitor training compliance metrics and ensure timely remediation of overdue or incomplete training.
• Collaborate with QA, Manufacturing, MSAT, QC, Supply Chain, and Clinical Operations to ensure training alignment with operational readiness for CGT activities.
• Support internal and external regulatory inspections by providing training records, system documentation, and SME-level responses.
• Lead deviation investigations or CAPAs related to LMS or training failures.
• Ensure GMP/GDP compliance for employees, contractors, and external partners involved in CGT workflows.
• Lead the development of competency-based training frameworks tailored for CGT manufacturing and quality operations.
• Implement improvements to training effectiveness, onboarding workflows, and qualification programs for roles such as aseptic operators, vector manufacturing personnel, and QTC oversight teams.
• Partner with functional leaders to evaluate training gaps and implement proactive training solutions.
• Manage periodic system evaluations and support upgrades or configuration changes within Compliance Wire.
• Act as the primary point of contact for all LMS-related questions and training system capabilities.
• Provide guidance to SMEs and content owners on training content development, assessments, and multimedia materials.
• Deliver training to employees on the use of Compliance Wire and GxP training requirements.

QUALIFICATIONS 

• Bachelor’s degree in Life Sciences, Biotechnology or a related field.
• Minimum 5 years of experience in biotechnology, pharmaceutical, or life sciences industry.
• 5–8+ years of Quality Assurance or training systems experience in a GxP environment; at least 3 years working specifically with Compliance Wire.
• Strong understanding of Cell and Gene Therapy regulations, including FDA guidance for ATMPs, EU ATMP frameworks, GTP (21 CFR 1271), and GMP/GDP expectations.
• Experience supporting audits and regulatory inspections.
• Experience in autologous or allogeneic CGT manufacturing, viral vector production, or Qualified Treatment Center (QTC) training programs.

 Preferred

• Experience designing competency-based training programs for high-risk operations (e.g., aseptic processing, cryopreservation, chain-of-custody/chain-of-identity workflows).
• Strong communication, problem‑solving, and cross‑functional leadership skills.
• Proactive approach to problem-solving, training effectiveness, and continuous improvement.