GMP Quality Assurance Consultant – Cell & Gene Therapy

Location: Boston, MA | Duration: Long Term

About the Role

We are seeking an experienced GMP Quality Assurance Consultant to provide quality oversight and compliance support for Cell & Gene Therapy manufacturing operations, validation, laboratory, engineering, and capital projects in a GMP-regulated environment.

Responsibilities

• Provide GMP QA oversight for manufacturing operations, validation, analytical laboratories, and engineering activities.
• Review and support Change Controls, Validation Protocols, Risk Assessments, GMP Investigations, and CAPA.
• Support equipment qualification, calibration, preventive maintenance, and laboratory operations.
• Review equipment, facility, and utility trending programs.
• Support environmental monitoring (EM), routine testing, and facility control systems.
• Collaborate with cross-functional teams to ensure GMP compliance and timely issue resolution.

Requirements

• 5–8+ years of GMP Quality Assurance experience in pharmaceutical, biotechnology, or Cell & Gene Therapy environments.
• Experience supporting GMP manufacturing operations, validation, and capital projects.
• Strong knowledge of GMP, QA, CAPA, Root Cause Analysis, Change Control, Risk Assessments, and aseptic processing.
• Experience with Veeva, Nuvolo, ViewLinc, or similar quality management systems.
• Bachelor’s degree in Engineering, Life Sciences, or a related field (Master’s preferred).

Skills

• Excellent communication, analytical, and problem-solving skills.