QA Operations Lead: External Manufacturing & Compliance

Genetix Biotherapeutics

Boston (MA)

Hybrid

USD 115,000 - 125,000

Full time

14 days+

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Benefits offered by this job

Health insurance

401(k) matching

Paid holidays

Paid parental leave

Tuition reimbursement

Job summary

Genetix Biotherapeutics seeks an Associate Manager, Quality Assurance Operations to provide QA oversight of external manufacturing partners, ensuring cGMP compliance and Genetix quality standards. You will partner with Manufacturing, MS&T, Quality Control, and Patient Supply teams and CMOs to govern deviation management, change controls, and quality system reviews.

The role requires 4–6 years in QA within GMP biopharma or cell/gene therapy, plus a Bachelor’s in Life Sciences (advanced degree

Qualifications

Bachelor’s degree in Life Sciences, Engineering, or related discipline (advanced degree preferred)
4-6 years of experience in Quality Assurance within GMP-regulated biopharmaceutical or cell/gene therapy manufacturing
Strong experience supporting CMO oversight and external manufacturing environments

Responsibilities

Provide on-call QA support for manufacturing operations, ensuring proactive identification, escalation, and mitigation of quality events and risks impacting ongoing manufacturing and product disposition
Maintain a consistent and effective external oversight model, including leading QA-to-QA forums and guiding quality discussions in joint governance meetings with CMOs
Support regular internal Deviation/Lab Investigation Management meetings, ensuring compliance, quality, and timeliness
Review and Approve internal and external CMO Deviations and Change Controls
Serve as QA point-of-contact for Product Complaints, ensuring appropriate investigation, documentation, and closure
Perform Quality Impact Assessments for Change Controls, ensuring appropriate risk evaluation and mitigation
Represent Quality Assurance Operations in Manufacturing Tier meetings, ensuring alignment on quality risks, priorities, and escalation pathways
Represent Quality Assurance Operations in Change Control Review Board (CCRB) meetings
Serve as QA reviewer and approver for: process validation protocols and reports, technical reports and supporting documentation, and internal and external validation deliverables
Monitor CMO quality performance metrics, identify trends, and drive continuous improvement initiatives
Own and manage CMO Quality Agreements, including authoring, reviewing, negotiating, and maintaining compliance with current regulatory expectations
Author and review Annual Product Quality Reviews (APQRs) to ensure comprehensive evaluation of product and process performance
Identify trends, risks, and opportunities for improvement across the product lifecycle