Quality & Regulatory Specialist

Department: Quality & Regulatory Reports to: Director, Quality & Regulatory Entity: Gift of Life Biologics FLSA Status: Exempt Position Summary The Quality & Regulatory Specialist will maintain compliance with applicable global regulatory requirements across all quality systems and operations for Gift of Life Biologics. The specialist serves as the 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 promptly. The role is client‑facing, representing Gift of Life Biologics’ quality and regulatory programs with professionalism and technical confidence. Key Responsibilities Quality Management Systems Author, review, and maintain Standard Operating Procedures, forms, work instructions, and quality policies in accordance with applicable regulations. Support the design and continuous improvement of the Quality Management System, including CAPA, deviation management, change control, and document control processes. Monitor quality metrics and KPIs; escape 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. Regulatory Compliance 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 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. Quality Audits 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. Client & Cross‑Functional Collaboration Build and maintain strong working relationships with clients, serving as a trusted quality partner and primary quality contact for assigned 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. Regulatory Knowledge Requirements The following regulatory frameworks are expected to be understood and applied in this role: FDA 21 CFR Part 211 – GMP for finished pharmaceuticals covering facilities, equipment, production, laboratory controls, and records FDA 21 CFR Part 1271 – Human cells, tissues, and HCT/P products including donor eligibility, manufacturing, labeling, and adverse reaction reporting FDA 21 CFR Part 11 – Electronic records and electronic signatures including audit trails, access controls, and system validation requirements EMA EudraLex Volume 4 (EU GMP) – EU GMP guidelines including Annex requirements for sterile manufacturing, computerized systems, and Qualified Person responsibilities Therapeutic Goods Act – Australian manufacturing license obligations, GMP clearance requirements, and compliance standards Health Canada C.02.006–C.02.011 / GUI‑0001 – Canadian GMP regulations governing manufacturing practices and quality control independence EMA/UK Regulation (EU) 2024/1938 – Standards of quality and safety for substances of human origin (SoHO) Qualifications Education 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. Experience 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. Skills & Competencies 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. Working Conditions 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. About Gift of Life Biologics 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. #J-18808-Ljbffr Gift of Life Marrow Registry