Associate Director, Quality Compliance

About the role

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.

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

Additional Information

The pay transparency range provided below is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. This role is eligible for an annual bonus and long-term incentive. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.

Genetix’s total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include comprehensive health, life and disability insurance, employer-matched 401(k) plan, lifestyle spending account, flexible time-off + paid holidays and winter holiday period, tuition reimbursement & loan repayment assistance, paid parental leave, paid onsite parking, commuter subsidy, and much more.

Pay Transparency
$144,000 - $195,000 USD

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.