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.

SUMMARY

The Lead Specialist, QA Operations Lot Disposition supports timely and compliant release of externally manufactured drug product, viral vector materials, and vendor‑supplied starting materials used in gene therapy programs. This role serves as a subject‑matter resource within the team, guiding junior reviewers, coordinating documentation flow, and helping ensure right‑first‑time disposition packages. The Lead Specialist partners closely with External Manufacturing, Quality, Supply Chain, and Technical Operations to keep batch documentation on track and audit‑ready.

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

RESPONSIBILITIES

• Coordinate completion and review of lot disposition packages, ensuring timely batch record, CoA/CoC, deviation, and supporting documentation readiness.
• Perform detailed quality review of batch records and supporting documents for external DP and viral vector manufacturing.
• Support review and release of vendor‑provided starting materials and raw materials used in gene therapy processes.
• Serve as a point of contact for documentation questions from internal teams and external manufacturing partners.
• Track lot status and proactively identify risks, gaps, or delays in documentation availability.
• Assist with investigation summaries, data reconciliation, and communication of document issues to cross‑functional teams.
• Support audit and inspection readiness by ensuring disposition files remain complete, accurate, and organized.
• Provide documentation and information during internal/external audits and help prepare responses.
• Drive and support process improvements and operational excellence initiatives related to the documentation and disposition workflow.
• Mentor or guide junior specialists on documentation expectations, quality standards, and system navigation.
• Support User Acceptance Testing and implementation of a digitalized CGT lot disposition process
• Proactively identify and drive operational excellence opportunities within the lot disposition process to enhance efficiency, reduce cycle time, and strengthen compliance.

QUALIFICATIONS

• Bachelor’s degree in a STEM discipline preferred (Biology, Biotechnology, Chemistry, Engineering).
• 4+ years of experience in a regulated biopharmaceutical, gene therapy, biologics, or medical device environment.
• Hands‑on experience with GMP documentation, batch record review, or lot disposition activities.
• Familiarity with external manufacturing environments (CMOs/CDMOs).
• Proficiency with electronic systems such as eQMS, document management platforms, or LIMS.
• Strong organizational skills with excellent attention to detail.
• Ability to interpret procedures, quality standards, and regulatory expectations.
• Effective communication skills for cross‑functional and external partner interaction.

 PREFERRED QULIFICATIONS:

• Experience with viral vector or biologics manufacturing.
• Exposure to raw material qualification or material release processes.
• Understanding of FDA regulations for advanced therapies.

SUMMARY

The Manager, Quality Systems, is responsible for overseeing key elements of the Quality Management System (QMS) that support manufacture, and release of gene therapy products. This role manages the end‑to‑end Complaint and Recall programs, ensures accurate and timely Quality Metrics reporting, drives closure of open quality system records, and supports continuous improvement initiatives and SOP lifecycle management.

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

RESPONSIBILITIES

• Oversee intake, triage, investigation, and closure of product quality complaints. Ensure complaint investigations are thorough, scientifically sound, and completed within required timelines.
• Manage the recall initiation, assessment, communication, and documentation process in compliance with regulatory expectations. Maintain recall readiness, including procedures, training, and mock recall exercises.
• Lead collection, analysis, and reporting of Quality Metrics (e.g., complaint cycle time, deviation aging, CAPA effectiveness)
• Lead routine cross‑functional meetings to review and drive timely closure of deviations, CAPAs, change controls, complaints, and other QMS records. Track action items, assign ownership, and ensure adherence to deadlines.
• Serve as the QA reviewer/approver of internal quality system records.
• Lead and support SOP revisions ensuring clarity, compliance, and alignment with business processes.
• Facilitate cross‑functional reviews, training, and implementation of updated procedures.
• Support quality improvement initiatives that enhance QMS performance, efficiency, compliance, and data integrity.
• Support internal audits and inspections.

QUALIFICATIONS

• Bachelor's or Master's degree in Life Sciences, Engineering, or related field.
• Minimum 5 years of experience in biotechnology, pharmaceutical, or life sciences industry.
• Experience with electronic QMS platforms (e.g., Veeva Vault).
• Strong communication, problem‑solving, and cross‑functional leadership skills.

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.

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

SUMMARY 

Manage Quality Approval (qualification) of vendors including R&D, GMP and treatment centers (apheresis collection centers and cell therapy labs) by performing qualification audits and routine (requalification) audits.

Oversee R&D compliance for Genetix clinical studies and Support other Quality Compliance functions, which may include but are not limited to:

• Planning and conducting internal audits
• Assisting with inspection readiness efforts
• Supporting GxP inspection readiness and regulatory inspections

RESPONSIBILITIES

• Collaborate with internal stakeholders (e.g., Apheresis Operations, Commercial, and Clinical Development) and external stakeholders to coordinate and prioritize audits
• Schedule and execute external and internal audits
• Ensure audit observations are communicated, tracked, and remediated in compliance with internal policies and applicable regulatory requirements
• Update approved vendor list, vendor and audit records and develop risk-based audit schedules
• Support annual budget development for outsourced audits
•  Manage Investigator Site Audit Plans for clinical studies
• Develop and present vendor metrics at Management Review
• Oversee R&D quality related activities
• Serve as QA contact for QMS records such as external and internal QMS records and lead investigations, deviations, change controls, and CAPAs, especially those involving CGT clinical operations, analytical activities, or site compliance related
• Serve as compliance lead for clinical studies
• Ensure QA supporting documentation is submitted to the TMF, as applicable
• Serve as QA contact for review and approval of Clinical SOPs
• Perform Regulatory Document Reviews, as applicable
• Provide quality oversight across CGT clinical studies, ensuring GCP compliance, data integrity, and proper documentation throughout clinical execution
• Ensure clinical trial sites are inspection‑ready and provide quality guidance to external partners, CROs, and CGT clinical facilities, ensuring alignment with internal quality standards and regulatory requirements.
• Act as the SME and primary point of contact for inspection management, providing real‑time regulatory guidance.
• Partner with Clinical Operations, Regulatory, and Vendor Management teams to identify and mitigate study specific quality risks throughout the trial lifecycle

QUALIFICATIONS

• 8-10 years of experience in gene therapy/cell therapy/biotech/or other related and regulated industry
• 8–10+ years of experience in R&D Quality
• Experience auditing investigator sites, GMP and R&D vendors and apheresis collection centers and cell therapy labs
• Knowledge of FACT/JACIE requirements
• Demonstrated experience in GCP compliance, clinical trial oversight, inspection readiness, and regulatory interaction
• Direct experience leading clinical deviations, CAPAs, change controls, and investigations
• Experience partnering with Clinical Operations, Regulatory, and cross‑functional stakeholders to manage clinical quality risks

 Preferred Qualifications

• Experience with CGT‑specific clinical QA such as:
• Apheresis and cell handling
• Chain‑of‑custody / chain‑of‑identity systems
• Strong understanding of CGT‑specific analytical and technical quality processes and technical Quality oversight.
• Excellent communication and stakeholder influence skills to support global, cross‑functional clinical programs