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The Product Quality Lead (APQR & QA CMC Support) is a key member of the QA Compliance organization, responsible for ensuring quality oversight of regulatory submissions and lifecycle management for Genetix Biotherapeutics (GTX) products. This role supports both clinical and commercial programs manufactured or tested at external CMOs and CTOs.

The position ensures compliance with US and EU GMP requirements across the full product lifecycle—from development, validation, and tech transfer through clinical/commercial manufacturing and batch disposition. Core responsibilities include providing strategic quality input, technical review of validation and transfer documentation, and oversight of equipment qualification, method validation, and shipping validation activities.

This role also leads regulatory impact assessments, annual product quality reviews, and supports escalation management for manufacturing/testing events requiring regulatory interaction. Additionally, the Associate Director partners cross-functionally and with external vendors to support health authority inspection readiness activities, mock inspections and internal audits.

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

Job Duties/Key Responsibilities

• Lead quality oversight of GTX product lifecycle activities, ensuring compliance with regulatory requirements (e.g., PAS, CBE-30 submissions, data verification, and inspection readiness).
• Provide strategic QA support for regulatory submissions and responses to Health Authority inquiries.
• Partner with internal teams and CMOs/CTOs to develop and execute compliant tech transfer strategies; review and approve protocols and reports (process, methods, equipment, and shipping validation).
• Support manufacturing operations by ensuring timely and compliant escalation and resolution of deviations and quality events.
• Collaborate with cross-functional and external partners during submission activities and post-approval inspections.
• Ensure consistent application of quality standards across lifecycle management initiatives.
• Monitor project timelines and ensure adherence to key milestones.
• Review and approve GMP documentation for compliance with internal procedures and global regulatory requirements.
• Lead and compile Annual Product Quality Reviews (APQRs).
• Proactively identify risks and drive resolution using sound judgment and strategic problem-solving.

Required Education, Experience, or Qualifications (or equivalent)

• Education/Experience: Bachelor’s degree (or equivalent) with 10+ years of experience in Quality Assurance or a related GxP environment.
• Technical Expertise:
  • Strong background in validation disciplines (process, method, cleaning, equipment, facilities/utilities, shipping/cold chain).
  • Experience supporting product lifecycle management, lot disposition, deviations, and change control.
  • Demonstrated experience with CMOs/CTOs, including quality agreements and external partner oversight.
• Regulatory Knowledge:
  • In-depth knowledge of US/EU GMP and ICH guidelines (Q7, Q8, Q9, Q10).
  • Hands-on experience with regulatory submissions and inspection readiness.
• Leadership & Competencies:
  • Proven ability to influence cross-functional and external stakeholders.
  • Strong analytical and decision-making skills with the ability to manage complex issues.
  • Excellent communication skills, with the ability to engage at all organizational levels.
  • Demonstrated success in fast-paced environments with competing priorities.
  • Strong project management and organizational skills with attention to detail.

Core Competencies

• Strategic thinking and problem-solving
• Cross-functional collaboration and stakeholder engagement
• Quality systems and regulatory compliance expertise
• Operational excellence and execution
• Inspection readiness and risk management knowledge & expertise