Head of Quality Assurance
Core
Establishing, scaling, and leading the Quality Assurance (QA) team to ensure GxP compliance for bioprinted tissue therapeutics from development through clinical manufacturing.
Role type
Head of Quality Assurance (GMP-regulated biotech)
Builds
Bioprinted tissue therapeutics for endocrine and metabolic diseases
Domain
Biotechnology / Regenerative Medicine / Cell & Gene Therapy
Deliverable
client delivery
Required skills
GMP compliance, Quality Management System (QMS) design, regulatory inspection readiness, CAPA management, data integrity, team leadership, regulatory submission authoring
Preferred skills
Cell/Gene Therapy experience, Advanced Therapy Medicinal Products (ATMPs) knowledge, ASQ CQA/CQM certification
Technologies
None stated
Responsibilities
Establish and maintain a phase-appropriate, GMP compliant Quality Management System (QMS); Own and oversee core QA functions including Document Control, Training, Change Control, Deviations, CAPA, and OOS investigations; Serve as Management Representative and lead inspection readiness activities; Lead Quality oversight for the GMP Cell Manufacturing facility; Provide support to QC functions for method validation and release testing; Ensure data integrity for GxP analytical and nonclinical data; Build and lead a high-performing QA team; Collaborate cross-functionally on regulatory submissions (IND, CTA)
Seniority
Senior, hands-on IC with leadership scope
