Senior QA Lead - Clinical Packaging & Labeling

Planet Pharma; Waltham (MA); On-site; USD 85,000 - 99,000; Full time

Job summary

Planet Pharma seeks a Quality Assurance Manager – Clinical Packaging and Labeling to oversee GMP QA for packaging at CMOs, ensure compliant labeling and release of IMPs, and drive risk-based quality decisions across the clinical supply lifecycle.

Leading QA oversight, deviation investigations, CAPAs, and change controls, you will collaborate with Regulatory Affairs, Clinical Operations, and CMOs to support timely clinical supply and inspection readiness.

Qualifications

• Bachelor’s degree in science or related field required.
• 7+ years in Pharmaceutical QA, quality operations, or GMP-regulated function.

Responsibilities

• Provide GMP QA oversight for clinical packaging and labeling operations at CMOs.
• Review batch records, master batch records, label text and proofs; ensure compliance with protocols and regulations.
• Support vendor qualification and ongoing oversight; participate in CAPA and continuous improvement.
• Support QA during clinical supply planning, packaging campaigns, and labeling strategies.
• Coordinate with stakeholders to resolve release issues and maintain supply timelines.

Skills

QA leadership

Documentation review

Vendor oversight

Risk assessment

Inspection readiness

Education

Bachelor’s degree in science

Job description

Planet Pharma seeks a Quality Assurance Manager – Clinical Packaging and Labeling to oversee GMP QA for packaging at CMOs, ensure compliant labeling and release of IMPs, and drive risk-based quality decisions across the clinical supply lifecycle.

Leading QA oversight, deviation investigations, CAPAs, and change controls, you will collaborate with Regulatory Affairs, Clinical Operations, and CMOs to support timely clinical supply and inspection readiness.