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.
What you'll do:
Regulatory Compliance
•Ensure organizational compliance with FDA 21 CFR Part 1271, cGTPs, AATB standards, and all applicable federal, state, and local requirements.
•Monitor regulatory changes and proactively update company policies, procedures, and SOPs to maintain compliance and industry best practices.
•Prepare for, lead, and represent the organization during regulatory inspections, third-party audits, and accreditation assessments.
•Manage regulatory submissions, facility registrations, and state tissue bank licenses; ensure timely renewals and filings.
•Oversee audit responses, corrective actions, and risk mitigation activities.
Quality Management System (QMS)
•Lead development, implementation, and maintenance of a robust QMS aligned with cGTPs and AATB standards.
•Oversee document control, change management, CAPA, deviation investigations, complaint handling, and continuous improvement initiatives.
•Approve and maintain SOPs, policies, controlled documents, and training records to ensure operational compliance.
•Establish metrics and KPIs to monitor quality performance and compliance trends.
•Lead internal audit programs and management reviews to ensure QMS effectiveness.
Product Release & Traceability
•Oversee product release processes, ensuring documentation meets quality and regulatory requirements.
•Ensure robust traceability systems are in place to track HCT/Ps from donor receipt through processing, storage, and distribution.
•Monitor labeling, packaging, storage, and distribution practices to ensure product integrity and regulatory compliance.
•Partner with supply chain and logistics teams to ensure compliant handling and transportation.
Training & Education
•Develop and maintain compliance-focused training programs across the organization.
•Ensure personnel competency in SOPs, quality requirements, and applicable regulations.
•Conduct periodic compliance training and oversee training record management.
Leadership & Collaboration
•Lead and mentor the Quality & Regulatory Compliance team; build organizational capability and succession planning.
•Provide strategic guidance to senior leadership on compliance risks, trends, and mitigation strategies.
•Partner cross-functionally with Supply Chain, Operations, Clinical Affairs, R&D, and Commercial functions to ensure alignment and quality oversight.
•Serve as the primary contact with regulatory bodies, accreditation agencies, contract manufacturers, and tissue bank partners.
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.