Quality Assurance Specialist

We are seeking an experienced Quality Engineering & Validation Consultant to provide GMP Quality oversight in support of manufacturing operations, validation activities, and capital projects within a regulated biopharmaceutical environment. This individual will partner cross-functionally with Manufacturing, Engineering, Validation, Facilities, Materials Management, and Quality teams to ensure compliance with GMP requirements while supporting clinical and commercial operations.

This role is ideal for a hands‑on Quality professional with strong validation, investigation, and CAPA experience who thrives in a fast‑paced manufacturing environment.

• Provide Quality oversight for GMP manufacturing operations, validation activities, and capital projects supporting clinical and commercial production.
• Review and approve quality documentation, including change controls, validation protocols, risk assessments, investigations, and CAPAs.
• Partner cross‑functionally with Manufacturing, Engineering, Validation, Facilities, Laboratory Operations, and Materials Management to ensure GMP compliance.
• Support equipment, facility, and utility qualification activities, including calibration, preventive maintenance, work orders, and instrument qualification.
• Review and approve equipment, facility, and utility trending programs while identifying compliance risks and driving resolution of quality issues.
• Support environmental monitoring, facility control systems, and related quality programs to ensure inspection readiness and regulatory compliance.
• Apply risk‑based decision making while identifying process improvements and communicating quality risks to project teams and leadership.

• BS degree in Engineering, Life Sciences, or a related technical discipline (Master's degree preferred).
• 8+ years of Quality Assurance experience supporting GMP manufacturing operations within the pharmaceutical, biotechnology, or cell & gene therapy industry.
• Experience providing Quality oversight for validation activities, engineering projects, and capital equipment.
• Strong experience leading or supporting GMP investigations, root cause analysis, CAPA, change controls, and risk assessments.
• Working knowledge of aseptic manufacturing and GMP regulations.
• Experience with electronic quality systems such as Veeva, Nuvolo, View Linc, or similar platforms.
• Excellent communication, collaboration, and problem‑solving skills with the ability to work effectively across cross‑functional teams.

• Experience supporting cell and gene therapy manufacturing.
• Experience working in both clinical and commercial manufacturing environments.
• Strong understanding of equipment qualification, facility validation, and utilities within GMP operations.