Quality Assurance Manager, GMP Operations

The Quality Assurance Manager, GMP Operations leads quality assurance for clinical cell-therapy manufacturing, with primary ownership of GMP operations quality — batch disposition support, floor quality, deviation and CAPA management, and change control. This manager-level role owns the day-to-day QA-GMP function, partners closely with Manufacturing, QC, Analytical Development, and Technical Operations, and ensures product quality and cGMP compliance across in-house manufacturing operations. The role combines hands-on execution with ownership of quality systems and processes, and provides leadership, mentorship, and quality oversight as the organization scales toward later-stage clinical development.

Key Responsibilities

Quality Operations & Batch Disposition

•      Own GMP operations quality for in-house cell-therapy manufacturing, serving as the primary QA point of contact on the manufacturing floor (“Quality on the Floor”).

•      Lead technical review of executed Batch Manufacturing Records, logbooks, QC testing records, and validation/calibration documentation.

•      Support and coordinate drug product disposition and release activities in partnership with the quality release authority.

•      Provide QA oversight for raw material, in-process, and sample release decisions and QC sample submission workflows.

Deviations, CAPA & Change Control

•      Own and manage complex deviations and investigations; lead root-cause analysis and drive effective CAPA plans to closure.

•      Lead and coordinate change controls (assessment, approval, verification) and risk assessments (impact analyses, FMEA) across manufacturing programs.

•      Identify, trend, and escalate quality issues; drive timely, compliant resolution.

Quality Systems & Documentation

•      Author, revise, and approve SOPs, work instructions, and quality documents; manage document lifecycle, versioning, and training in the document control system.

•      Maintain and improve the electronic quality management system (eQMS) and associated records.

•      Establish, track, and analyze QA metrics and trends (deviations, CAPA, audit findings); present actionable insights to leadership.

Audits & Inspection Readiness

•      Serve as a primary QA lead for internal and external audits and regulatory inspections of manufacturing operations; prepare responses, corrective actions, and follow-up.

•      Drive and maintain ongoing inspection readiness across GMP operations.

Manufacturing & Technical Operations Partnership

•      Partner with Manufacturing and Technical Operations on process improvements, validation studies, tech transfer, and scale-up, providing quality guidance and oversight.

•      Support manufacturing changes and comparability activities from a quality standpoint.

•      Interface with suppliers and contract manufacturing/testing partners on quality matters; support supplier qualification and oversight.

Leadership & Team Development

•      Lead, mentor, and develop QA staff; set clear expectations, priorities, and escalation paths.

•      Foster a proactive quality culture and continuous-improvement mindset across the organization.

•      Represent GMP operations quality in cross-functional and leadership forums, and help build out the QA function as the company grows.

Qualifications & Technical Skills

Required

•      Bachelor’s degree in a scientific, technical, or regulatory discipline.

•      Minimum 8 years in a cGMP environment with progressive QA responsibilities, including direct experience in GMP manufacturing operations quality and people or functional leadership.

•      Demonstrated ownership across multiple QA functions: batch review/release, deviations/CAPA, change control, document control, and audits/inspections.

•      Hands-on experience leading deviations, CAPAs, audits, and change controls in a GMP manufacturing setting.

•      Strong knowledge of cGMP and FDA regulations and expectations for cell and gene therapies (or complex biologics).

•      Proficiency with eQMS, document control systems, and QC data workflows (LIMS or similar a plus).

•      Experience with risk assessments (e.g., FMEA), validation documentation review, and supplier quality oversight.

Preferred

•      Prior experience with cell-therapy or advanced-therapy products (CAR-T, TCR, cell-based biologics; experience with xenogeneic or other non-standard cell products a plus).

•      Experience supporting in-house GMP manufacturing and product disposition/release.

•      Experience in a small or growing clinical-stage company, operating hands-on without large infrastructure.

•      Experience supporting tech transfer, scale-up, and manufacturing changes.

Competencies

•      Proven leadership and stakeholder management — able to lead a team, influence cross-functional partners, and drive timely resolutions.

•      Sound, independent quality judgment and risk-based decision-making.

•      Strong root-cause / problem-solving skills and excellent written and verbal communication.

•      High attention to detail and commitment to compliance, balanced with practical, phase-appropriate judgment.

•      Able to work independently and manage multiple priorities in a fast-paced, evolving environment.

•      Experience mentoring staff and leading QA projects and improvement initiatives.