Director of Quality Assurance – Therapeutics Division

Director of Quality Assurance – Therapeutics Division Direct message the job poster from PONYA LABORATORY SERVICES At Ponya Lab Services, we bring clarity through science - delivering fast, accurate, and reliable lab results to support better clinical decisions and patient care. Based in Atlanta, GA and serving providers nationwide, our state-of-the-art medical laboratory specializes in Toxicology, STI and UTI screening, and Pharmacogenomic (PGX) Testing. We are committed to quality, safety, and scientific integrity - ensuring providers have reliable access to high quality tissue-based products that support clinical care. Overview Role Description: Ponya Lab Services is seeking a seasoned Quality Assurance professional for our Therapeutics Division to lead Quality Assurance and compliance across our biologics, regenerative medicine, device, and wound care product line and pipeline. Responsibilities The successful candidate will complete the implementation of a 21 CFR 1271, 21 CFR 820, and ISO 13487 compliant Quality Management System and ensure inspection readiness. Proventrue expertise in all aspects of Quality including Change Management, Risk Management, Deviations and CAPA, Supplier Qualification and Management, Equipment Qualification, Materials Management, and Process Validation is required. Experience in Design Controls and the pre-commercial phases of medical device development is desirable but not required. Candidates with experience in providing Quality support to an ISO 14644-compliant cleanroom facility will be given preference. The successful candidate will have a B.S. degree or higher in a scientific discipline or biomedical engineering to bridge Quality Assurance and a technical understanding of our tissue-based products and our patient populations. If you have 10 + years of Quality leadership experience in biotech, pharma, or medical devices, a deep understanding of regulatory frameworks, and a passion for patient-centered innovation, this is your opportunity to shape the future of Therapeutics. Qualifications B.S. degree or higher in a scientific discipline or biomedical engineering. 10+ years of Quality leadership experience in biotech, pharma, or medical devices. Strong knowledge of regulatory frameworks (21 CFR 820, 21 CFR 1271, ISO 13487) and related quality systems. Experience with Change Management, Risk Management, Deviations and CAPA, Supplier Qualification and Management, Equipment Qualification, Materials Management, and Process Validation. Desirable: Design Controls experience and pre-commercial medical device development knowledge. Desirable: ISO 14644-compliant cleanroom experience. About Ponya Lab Services Ponya is a diverse company with a culture of cross-functional teamwork, collaboration, and excellence in innovation. Location: Atlanta, GA Salary: $140,000.00-$155,000.00 #J-18808-Ljbffr

Created: 2025-09-18