Clinical GMP Quality Assurance Manager

JMD Technologies Inc.; Waltham (MA); Hybrid; USD 90,000 - 99,000; Full time

Job summary

JMD Technologies Inc. is seeking an experienced Clinical GMP Quality Assurance Manager in the Greater Waltham, MA area. This contract role provides quality oversight for clinical packaging, labeling, and finished goods to support clinical development programs.

You will ensure GMP compliance across clinical supply activities, CMOs, packaging operations, and material release. Strong collaboration with Clinical Supply Chain and Regulatory Affairs is essential to maintain uninterrupted clinical

Qualifications

• Bachelor's degree in a scientific discipline, pharmaceutical sciences, or related field.
• Typically 7+ years of experience in Pharmaceutical Quality Assurance or GMP environments.
• Hands-on experience with clinical packaging and labeling operations.
• Experience reviewing and approving clinical packaging/batch records and label proofs.
• Knowledge of clinical trial material release, IMP disposition, and expiry extension processes.
• Strong understanding of GMP regulations, deviations, investigations, CAPA, and change control.

Responsibilities

• Provide GMP Quality Assurance oversight for clinical packaging and labeling activities performed by external manufacturers and packaging partners.
• Review and approve clinical packaging records, master batch records, label text, proofs, and related quality documentation.
• Support clinical material disposition, IMP release, expiry extensions, and temperature excursion investigations.
• Oversee quality events, including deviations, investigations, CAPA, change controls, and product impact assessments.
• Manage CMO/vendor quality activities, review quality documentation, and support regulatory inspections and audit readiness.
• Partner with Clinical Supply Chain, CMC, Regulatory Affairs, and Clinical Operations teams to address quality issues and ensure uninterrupted clinical supply.
• Ensure packaging and labeling activities comply with GMP standards, approved procedures, and regulatory requirements.

Skills

GMP Quality Assurance

Clinical packaging

Labeling

Document review

Quality events/ CAPA

CMO oversight

Regulatory inspections

Cross-functional collaboration

Education

Bachelor's degree in a scientific discipline

Job description

Title: Clinical GMP Quality Assurance Manager

Location: Greater Waltham, MA Area (Hybrid - 3 days onsite/week)

Employment Type: Contract - 6 Months

Status: Accepting Candidates

About the Role

Seeking an experienced Clinical GMP Quality Assurance Manager to provide quality oversight for clinical packaging, labeling, and pharmaceutical finished goods operations supporting clinical development programs. This role will ensure GMP compliance across clinical supply activities, contract manufacturing organizations (CMOs), packaging operations, and clinical material release processes.

Key Responsibilities

• Provide GMP Quality Assurance oversight for clinical packaging and labeling activities performed by external manufacturing and packaging partners.
• Review and approve clinical packaging records, master batch records, label text, proofs, and related quality documentation.
• Support clinical material disposition, Investigational Medicinal Product (IMP) release, expiry extensions, and temperature excursion investigations.
• Oversee quality events, including deviations, investigations, CAPAs, change controls, and product impact assessments.
• Manage CMO/vendor quality activities, review quality documentation, and support regulatory inspections and audit readiness.
• Partner with Clinical Supply Chain, CMC, Regulatory Affairs, and Clinical Operations teams to address quality issues and ensure uninterrupted clinical supply.
• Ensure clinical packaging and labeling activities comply with applicable GMP standards, approved procedures, and regulatory requirements.

Qualifications

• Bachelor's degree in a scientific discipline, pharmaceutical sciences, or a related field; equivalent relevant experience may be considered.
• Typically 7+ years of experience in Pharmaceutical Quality Assurance, Quality Operations, or GMP-regulated environments.
• Hands-on experience supporting clinical packaging and labeling operations within the pharmaceutical or biotechnology industry.
• Experience reviewing and approving clinical packaging/labeling batch records, master batch records, label proofs, and supporting documentation.
• Knowledge of clinical trial material release, IMP disposition, temperature excursion assessments, and expiry extension processes.
• Strong understanding of GMP regulations, deviations, investigations, CAPA, change control, and external CMO quality oversight.
• Excellent communication and cross-functional collaboration skills.

Compensation (MA Pay Transparency)

• Estimated hourly range: $65-$72/hr (W-2).
• Final rate within this range will be based on skills, experience, and interview results.