Senior Quality Assurance Manager – GMP & Compliance Leader

THG; New Jersey; On-site; USD 95,000 - 105,000; Full time

Job summary

THG, Edison, NJ, is seeking a Quality Assurance Manager to lead QA activities across manufacturing, filling, packaging, and assembly. You will ensure product quality, regulatory compliance, GMP adherence, audit readiness, and continuous improvement through strong quality systems and CAPA management.

The role requires extensive QA leadership, investigations, and cross‑functional collaboration, plus 7+ years in regulated manufacturing and 3+ years of people management.

Qualifications

• Bachelor’s degree in a related field and strong QA foundations.
• 7+ years of Quality Assurance experience in a regulated manufacturing environment.
• 3+ years of people management experience.
• Experience leading investigations, CAPAs, change controls, audits, and quality systems.
• Strong knowledge of FDA regulations, cGMP, and ISO 22716.

Responsibilities

• Provide quality oversight across manufacturing and packaging operations.
• Lead deviations, investigations, root cause analyses, and CAPA management.
• Maintain audit and inspection readiness across quality systems.
• Promote documentation accuracy, data integrity, and traceability.
• Coach and develop QA personnel and support cross‑functional teams.

Skills

QA leadership

Regulatory knowledge

Investigations & CAPA

Data integrity

Documentation & traceability

Education

Bachelor’s degree in Chemistry, Biology, Quality Management, Engineering, Manufacturing, or related field

Tools

Microsoft Office

Electronic QMS

ERP systems

Job description

THG, Edison, NJ, is seeking a Quality Assurance Manager to lead QA activities across manufacturing, filling, packaging, and assembly. You will ensure product quality, regulatory compliance, GMP adherence, audit readiness, and continuous improvement through strong quality systems and CAPA management.

The role requires extensive QA leadership, investigations, and cross‑functional collaboration, plus 7+ years in regulated manufacturing and 3+ years of people management.