Quality & Regulatory Specialist in BOCA RATON, Florida at Gift of Life Marrow Registry Inc

Department: Quality & Regulatory
Reports to: Director, Quality & Regulatory
Entity: Gift of Life Biologics
FLSA Status: Exempt

The Quality & Regulatory Specialist is responsible for maintaining compliance with applicable global regulatory requirements across all quality systems and operations for Gift of Life Biologics. This role serves as a subject matter expert on pharmaceutical and biologics GMP regulations, supports internal and external quality audits, authors and maintains quality documentation, and partners cross-functionally to resolve quality issues in a timely and effective manner. The Specialist plays a key client-facing role, representing Gift of Life Biologics' quality and regulatory programs with professionalism and technical confidence.

• Author, review, and maintain Standard Operating Procedures (SOPs), forms, work instructions, and quality policies in accordance with applicable regulations.
• Support the design and continuous improvement of the Quality Management System (QMS), including CAPA, deviation management, change control, and document control processes.
• Monitor quality metrics and KPIs; escalate trends and systemic issues to quality leadership.
• Ensure all quality records are accurate, complete, and retrievable in compliance with 21 CFR Part 11 and applicable electronic records requirements.

Maintain up-to-date working knowledge of and ensure site compliance with the following regulations and guidance:

• FDA 21 CFR Part 211 — Current Good Manufacturing Practice for Finished Pharmaceuticals
• FDA 21 CFR Part 1271 — Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
• FDA 21 CFR Part 11 — Electronic Records and Electronic Signatures
• EMA — EU GMP Guidelines (EudraLex Volume 4, including relevant Annexes)
• EMA Guidance 1006.17EC Technical requirements for the donation, procurement and testing of human tissues and cells
• Commission Directive 2004/33/EC Certain technical requirements for blood and blood components
• Regulation (EU) 2024/1938, Standards of Quality and Safety for Substances of Human Origin
• Guidance on TGO 108: Standard for Human Cell or Tissue Products – Donor Screening Requirements, Australian Regulatory Guidelines for Biologicals
• Guidance on TGO 109: Standards for Biologicals – General and Specific Requirements, Australian Regulatory Guidelines for Biologicals
• CAN/CSA-Z9001:22, National Standard of Canada, Cells, Tissues, and Organs for Transplantation: General Requirements
• CAN/CSA-Z900.2.5:22, National Standard of Canada, Lymphohematopoietic Cells for Transplantation

Additional responsibilities include:

• Interpret new and revised regulations and communicate compliance impact to relevant stakeholders.
• Support regulatory submissions, responses to agency inquiries, and preparation of compliance gap analyses.

• Plan, conduct, and report internal GMP audits against applicable regulatory standards and internal procedures.
• Manage and execute supplier and vendor qualification audits; maintain the approved supplier/vendor list.
• Serve as a primary point of contact and host for client-conducted quality audits and regulatory inspections on behalf of Gift of Life Biologics, including preparation of audit-ready documentation, opening and closing meetings, and observation response activities.
• Author audit responses and corrective action plans; track commitments through closure and verify effectiveness.

• Build and maintain strong working relationships with clients, serving as a trusted quality partner and primary quality contact for assigned Gift of Life Biologics accounts.
• Collaborate with operations, manufacturing, supply chain, and R&D to identify, investigate, and resolve quality issues including deviations, OOS results, complaints, and non-conformances.
• Communicate quality findings clearly and professionally to both technical and non-technical audiences, both verbally and in writing.
• Participate in cross-functional project teams to provide quality oversight for new product introductions, process changes, and technology transfers.

The following regulatory frameworks are expected to be understood and applied in this role:

A substance of human origin (SoHO) is any substance collected from the human body, whether or not it contains cells and whether those cells are living or not, including preparations resulting from processing such substances.

• Bachelor's degree required in Life Sciences, Chemistry, Pharmacy, Biology, Engineering, or a closely related field.
• Advanced degree (M.S., Pharm.D., or equivalent) preferred.

• Minimum three (3) years of progressive Quality Assurance and/or Regulatory Affairs experience in a regulated industry, preferably within biologics, cell therapy, pharmaceutical manufacturing, contract manufacturing, or related life sciences environments.
• Demonstrated hands-on experience with quality systems including CAPA, change control, deviation management, and document control.
• Experience planning and executing internal GMP audits and supporting external audits or regulatory inspections.
• Familiarity with two or more of the regulatory frameworks listed above; multi-agency experience strongly preferred.

• Exceptional attention to detail with a rigorous, systematic approach to documentation and problem-solving.
• Strong written and verbal communication skills with the ability to produce clear, concise quality documents including SOPs, policies, audit reports, and regulatory responses.
• Client-facing professionalism with the ability to represent Gift of Life Biologics' quality standards in external-facing interactions.
• Collaborative, solutions-oriented mindset with the ability to work across functions to resolve quality issues without creating adversarial dynamics.
• Proficiency with electronic quality management systems (eQMS) and document management tools; experience with Part 11-compliant platforms preferred.
• Ability to prioritize and manage multiple concurrent projects in a fast-paced, deadline-driven environment.

• Primarily office-based with regular access to manufacturing and laboratory environments; applicable gowning and safety requirements apply.
• Domestic and international travel up to 20% for supplier audits, client audits, and regulatory meetings.
• May require occasional extended hours during audit preparation periods or in response to regulatory inquiries.

Gift of Life Biologics is a contract development and manufacturing organization (CDMO) specializing in cellular therapy and biologic products. The organization is committed to maintaining the highest standards of quality, regulatory compliance, operational excellence, and client service.

This job description is intended to convey information essential to understanding the scope of the position and is not exhaustive. Responsibilities may be adjusted to meet organizational needs.

Gift of Life Biologics is an equal opportunity employer.