What are the responsibilities and job description for the Director of Quality Assurance – Therapeutics Division position at PONYA LABORATORY SERVICES?
Company Description
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.
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.
- 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. Proven 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.
Ponya is a diverse company with a culture of cross-functional teamwork, collaboration, and excellence in innovation.