Job Description

Position Summary:

The Director of Quality Assurance is responsible for developing, implementing, and managing a comprehensive Quality Management System (QMS) that ensures compliance with FDA regulations (21 CFR Part 1271, 210/211), AATB standards, and other applicable regulatory and accrediting bodies. This leader will oversee quality assurance functions including internal audits, CAPAs, supplier quality, document control, and batch record review. They will also lead the QA team, drive continuous improvement initiatives, and serve as the company’s quality liaison with regulatory agencies and auditors.

Key Responsibilities:

• Provide strategic leadership for the QA department, ensuring alignment with business goals and regulatory requirements.
• Maintain and continuously improve the company’s QMS in compliance with FDA, AATB, ISO, and other relevant standards.
• Oversee quality systems including but not limited to: deviations, non-conformances, CAPAs, change control, batch record review, product release, and document management.
• Manage internal and external audits, including FDA inspections, customer audits, and third-party certifications.
• Serve as Management Representative for Quality; lead quality management reviews and metrics reporting.
• Partner cross-functionally with Regulatory Affairs, Manufacturing, R&D, and Supply Chain to ensure quality is integrated across all functions.
• Lead and mentor a team of QA professionals; ensure team development through coaching, training, and performance management.
• Oversee supplier qualification and monitoring programs.
• Support complaint handling and investigation processes, ensuring timely closure and root cause analysis.
• Stay current with evolving regulations and industry best practices; implement necessary changes to maintain compliance and improve processes.

Qualifications:

• Bachelor’s degree in Life Sciences, Engineering, or related field (Master’s preferred).
• Minimum of 8–10 years of experience in quality assurance within the biologics, tissue banking, or medical device industry.
• At least 5 years in a leadership or management role.
• In-depth knowledge of applicable regulations including 21 CFR Part 1271, 210/211, AATB, cGMPs, and ISO 13485.
• Experience with donor eligibility, tissue recovery, processing, packaging, and distribution is strongly preferred.
• Strong leadership, organizational, and communication skills.
• Proven track record of successfully managing audits and inspections.
• Ability to foster a culture of quality, compliance, and continuous improvement.

Preferred Certifications:

• Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or equivalent.
• AATB CTBS certification is a plus.

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