More jobs:
GMP Quality Assurance Consultant – Cell & Gene Therapy
Job in
Boston, Suffolk County, Massachusetts, 02298, USA
Listed on 2026-08-09
Listing for:
Stark Pharma Solutions Inc
Full Time
position Listed on 2026-08-09
Job specializations:
-
Quality Assurance - QA/QC
-
Healthcare
Data Scientist, Medical Science
Job Description & How to Apply Below
We are hiring talented professionals for a GMP Quality Assurance Consultant Cell & Gene Therapy position.
Position: GMP Quality Assurance Consultant Cell & Gene Therapy
Location: Boston, MA
Duration: Long Term
Job OverviewWe 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.
Key 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.
- 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, View Linc, or similar quality management systems.
- Bachelor's degree in Engineering, Life Sciences, or a related field (Master's preferred).
- Excellent communication, analytical, and problem-solving skills.
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×