Director of Quality & Regulatory Compliance

About the role

The Director of Quality and Regulatory Compliance is responsible for establishing, implementing, and managing a comprehensive quality system and regulatory strategy to ensure the procurement, processing, storage, and distribution of HCT/Ps are fully compliant with FDA 21 CFR Part 1271, AATB standards, state regulations, and internal quality objectives. This leadership role is critical in safeguarding product integrity, ensuring regulatory compliance, and protecting patient safety, while supporting organizational growth and operational excellence.

Qualifications

• Bachelor's degree in Life Sciences, Regulatory Affairs, Quality Assurance, Biomedical Engineering or related field; Master's degree preferred.
• Minimum of 7–10 years of progressive experience in quality and regulatory roles within the biologics, tissue banking, HCT/P, or medical device industry.
• In-depth knowledge of FDA 21 CFR Part 1271, cGTPs, and AATB standards.
• Demonstrated experience preparing for and leading FDA inspections, AATB accreditations, and third-party audits.
• Strong expertise in QMS development, implementation, and electronic documentation systems.
• Excellent analytical, communication, leadership, and problem-solving skills.
• Preferred Certifications: Certified Quality Auditor (CQA), Certified Quality Manager (CQM), or RAC certification. AATB CTBS (Certified Tissue Bank Specialist) strongly preferred. Additional quality/regulatory certifications (e.g., Six Sigma, ASQ certifications) a plus.