Quality Assurance Manager — GMP/Regulatory Lab Leader

Epicur; Mount Laurel Township (NJ); On-site; USD 72,000 - 88,000; Full time

Benefits offered by this job

Medical insurance

Dental coverage

Vision coverage

Life insurance

401(k) with match

Bonus program (semi-annual)

Job summary

Stokes Healthcare in Mount Laurel, NJ, seeks a Quality Assurance Manager to oversee STEP Labs Testing Facility operations, implement QA procedures, and maintain cGMP compliance. The role reports to the Laboratory Director/Managing Director and drives data integrity across testing processes.

The candidate will manage quality systems, support FDA/regulatory inspections, and lead investigations to improve product quality and reliability. Strong leadership and communication are essential.

Qualifications

• Minimum 8 years in analytical testing, microbiology testing, or pharma manufacturing (no degree) or 6+ years with degree.
• 3+ years supervisory experience preferred.
• Excellent communication and technical writing abilities.

Responsibilities

• Oversee quality systems and procedures to ensure cGMP and data integrity.
• Lead FDA/regulatory inspections and audits.
• Develop QA procedures to maintain compliance and reliability of lab procedures.
• Monitor regulatory requirements and implement corrective actions.
• Lead investigations for deviations and root-cause analyses.
• Ensure timely review and approval of testing documentation.
• Oversee calibration, validation, and maintenance of equipment.

Skills

Quality Assurance

Regulatory compliance

Leadership

Technical writing

Education

Bachelor’s Degree in Biological Science or related field

Tools

Microsoft Office

Job description

Stokes Healthcare in Mount Laurel, NJ, seeks a Quality Assurance Manager to oversee STEP Labs Testing Facility operations, implement QA procedures, and maintain cGMP compliance. The role reports to the Laboratory Director/Managing Director and drives data integrity across testing processes.

The candidate will manage quality systems, support FDA/regulatory inspections, and lead investigations to improve product quality and reliability. Strong leadership and communication are essential.