Associate Director, QA Global Central Laboratories
Core
Provide strategic and operational leadership for the Quality Assurance team supporting the primary Global Central Laboratories site, overseeing quality systems for clinical laboratory services, biorepository, and kitting operations.
Role type
Senior leadership QA Director (regulated laboratory)
Builds
Quality management systems, inspection readiness, and operational excellence for clinical diagnostics and biorepository services
Domain
Life Sciences / Clinical Laboratory / Biotechnology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Laboratory quality management systems, regulatory compliance (CLIA, CAP, ISO 15189, FDA, EMA, GMP/GLP), CAPA, investigations, root cause analysis, audit management, inspection readiness, data integrity, risk management, quality metrics
Preferred skills
Central laboratories, high-complexity laboratories, biorepositories, clinical research environments, Lean Six Sigma, ASQ Quality certifications
Technologies
None stated
Responsibilities
Lead and mentor QA professionals; Oversee quality management systems including deviations, investigations, CAPA, change control, document control, audits, training, risk management, and quality metrics; Ensure compliance with regulations and accreditation standards; Lead internal audits, client audits, regulatory inspections, and accreditation assessments; Partner cross-functionally to identify quality risks and implement process improvements; Monitor quality trends and analyze performance metrics; Support client interactions and regulatory responses
Seniority
Senior, hands-on IC with leadership mandate
