GMP QA Operations Lead – Cell-Therapy

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

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.