Quality Assurance Manager, GMP Operations

Planet Pharma; Germantown (MD); On-site; USD 110,000 - 150,000; Full time

Job summary

Planet Pharma is seeking a Quality Assurance Manager, GMP Operations, to lead QA for clinical cell-therapy manufacturing. The role owns floor quality, batch disposition support, deviations and CAPA management, change control, and audit readiness, partnering across Manufacturing, QC, and Technical Operations.

The ideal candidate has a minimum of 8 years in a cGMP environment with hands-on experience in GMP manufacturing quality, document control, and eQMS.

Qualifications

• 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 leadership.
• Hands-on experience leading deviations, CAPAs, audits, and change controls in a GMP manufacturing setting.
• Strong knowledge of cGMP and FDA regulations 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) and supplier quality oversight.

Responsibilities

• Own GMP operations quality for in-house cell-therapy manufacturing; QA point on the floor.
• Lead technical review of Batch Manufacturing Records, logbooks, QC testing records, and validation docs.
• Support and coordinate drug product disposition and release with quality release authority.
• Provide QA oversight for material release decisions and QC submission workflows.
• Lead deviations, CAPA investigations, and root-cause analysis; drive CAPA closure.
• Coordinate change controls and risk assessments across programs.
• Manage SOPs, documents, versioning, and training in the document control system.
• Maintain and improve the eQMS and related records.
• Establish QA metrics, trends, and present insights to leadership.
• Lead internal/external audits and regulatory inspections; ensure inspection readiness.
• Collaborate with Manufacturing/Technical Operations on process improvements and tech transfer.
• Interface with suppliers and contract partners on quality matters.

Skills

Deviations

CAPA

Audits

Change control

Document control

eQMS

LIMS

FMEA

Regulatory knowledge

Education

Bachelor’s degree in science/engineering/regulatory

Tools

eQMS

LIMS

Job description

Position Summary

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 escalation 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 analyse 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.

salary range: 110-150k
DOE