Genetix Biotherapeutics

Product Quality Lead (APQR & QA CMC Support)

Somerville, MA · Director · Full-time

Sponsorship not specified$144k-$195kDetected 12 days ago

ComplianceProduct ManagementProject ManagementGMPLeadershipCommunicationCollaborationProblem SolvingOrganizational SkillsGxP

About the role

This is personal and we approach every challenge with radical care.
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 is a full-time hybrid position (3 days a week) in our Somerville - Assembly Row, Massachusetts office.

Strong analytical and decision-making skills with the ability to manage complex issues.

Bachelor's degree (or equivalent) with 10+ years of experience in Quality Assurance or a related GxP environment.
Experience supporting product lifecycle management, lot disposition, deviations, and change control.
Demonstrated experience with CMOs/CTOs, including quality agreements and external partner oversight.
In-depth knowledge of US/EU GMP and ICH guidelines (Q7, Q8, Q9, Q10).
Hands-on experience with regulatory submissions and inspection readiness.

$144,000 - $195,000 USD
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.

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.
About Genetix Biotherapeutics
At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference.
When you join Genetix, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more days.

Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.

This listing is sourced directly from Genetix Biotherapeutics's careers page and normalized into a canonical job model.