Quality Manager

FPC of Greensboro, NC; Allentown (Lehigh County); On-site; USD 110,000 - 140,000; Full time

Job summary

FPC of Greensboro, NC seeks a Quality Manager to provide site-wide leadership across pharmaceutical operations, ensuring GMP/GDP compliance, inspection readiness, and strong quality performance in a controlled environment.

The role requires significant experience in GMP-regulated life sciences settings and proven ability to lead quality initiatives across a site. This position emphasizes ownership of quality programs and readiness for regulatory inspections.

Qualifications

• 7–10 years of progressive Quality or related experience in a GMP-regulated life sciences environment.
• Working knowledge of regulations and standards including 21 CFR Parts 11, 205, 211; EU GMP/GDP; USP; data integrity principles.
• Experience managing an ISO-grade cleanroom or equivalent controlled environment.
• Experience with pharmaceutical warehousing, sampling, chain of custody, or controlled environments.
• Demonstrated people leadership and ownership of a site Quality program or regulated operational area.

Education

Bachelor's degree in Biochemistry, Chemistry, Biology, Quality, Engineering

Job description

A growing life sciences organization is looking for a Quality Manager to provide site-level leadership across pharmaceutical operations and a specialized GMP/GDP + controlled-environment/cleanroom. The successful candidate will play a key role in maintaining compliance, strengthening quality performance, and ensuring operational and inspection readiness.

Required:

• Bachelor's degree in Biochemistry, Chemistry, Biology, Quality, Engineering, or another relevant STEM discipline.
• 7-10 years of progressive Quality or related experience in a GMP-regulated pharmaceutical, biotechnology, medical device, laboratory, or life sciences logistics environment.
• Working knowledge of applicable regulations and standards, including 21 CFR Parts 11, 205, and 211, EU GMP/GDP guidance, USP standards, and data integrity principles.
• Experience managing an ISO-graded cleanroom or equivalent controlled environment.
• Experience with pharmaceutical warehousing, sampling, chain of custody, or controlled environments.
• Demonstrated people leadership and ownership of a site Quality program or regulated operational area.