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Lead Specialist, QA Operations Lot Disposition

Genetix Biotherapeutics
Somerville, MA

Job Details

Full-time
$98,000 - $134,000 a year

Benefits

Free parking
Commuter assistance
Paid parental leave
Paid holidays
Disability insurance
Health insurance
Tuition reimbursement
Parental leave
401(k) matching
Loan assistance
Life insurance

Qualifications

Biology
Raw material quality management
Performance improvement leadership
Quality records maintenance
Document control experience within pharmaceutical industry
Pharmaceutical regulatory compliance
Filing
Laboratory information management systems
Biotechnology
GMP
Mid-level
Bachelor's degree in biology
Bachelor's degree in engineering
Professional development support
Team management
Pharmaceutical company experience
Compliance documentation
Mentoring
User acceptance testing
Vendor communication
Organizational skills
Chemistry
Collaboration with manufacturing teams
Operational excellence initiatives
Production batch record review
4 years
Pharmaceutical product quality management experience
Bachelor's degree in biotechnology
Process management
Quality control records management

Full Job Description

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. We are doers, thinkers and collaborators who embrace and live by our values:

Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.

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.

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

$98,000 - $134,000 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.

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