Sr. Manager, Quality Assurance for Quality Control
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 become part of a company pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers, and collaborators who embrace and live by our values: innovation rooted in diversity, cooperation, and radical care. This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.
About the role
The Sr. Manager, Quality Assurance for Quality Control manages contract testing organizations (CTOs) for all activities associated with Quality Control operation of in-process and release testing for raw materials, starting materials, and drug products in support of commercial operations. This position requires close partnering with CTOs and internal cross-functional teams to contribute significantly to the process of sample submission for release testing to Certificate of Analysis (COA) approval.
Responsibilities
- Manage Quality Control related communications within CTOs and contract manufacturing organizations (CMOs).
- Lead the Stability program focusing on annual commitments and regulatory filings.
- Build and maintain relationships with CTOs and CMOs to ensure issues impacting Quality Control testing are tracked and resolved promptly.
- Own and/or support current good manufacturing practice (cGMP) routine testing by managing quality systems for deviations, laboratory investigations, and CAPAs.
- Lead and/or collaborate with internal cross-functional teams and/or CxOs to review and document deviations, laboratory investigations, and CAPAs.
- Participate and provide updates on Quality Control lot status at various internal forums.
- Lead, support, and mentor team members in activities related to this role.
- Support process improvement initiatives across the quality department.
- Ensure all documentation complies with cGMP regulations and industry guidelines.
Requirements
- BS or MS in a scientific discipline with 5–10+ years of experience in a QC cGMP clinical and/or commercial environment.
- Experience managing CTOs and CMOs, with strong interpersonal and partner-management skills.
- Stability program management experience, including familiarity with ICH guidelines.
- Direct people-management experience, including management of teams or individual contributors.
- Excellent organizational skills and the ability to succeed in a fast-paced environment.
- Experience with quality systems supporting deviations, laboratory investigations, and CAPAs.
- Strong working knowledge of cGMP, ICH, FDA, and EMA regulations.
Benefits
- 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 and commuter subsidy.
Pay
Pay Transparency: $145,000 USD - $196,000 USD. This role is eligible for an annual bonus and long-term incentive. Actual base salary will be based on experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors.
Schedule
Full-time hybrid position (3 days a week in-office).