Director, Preclinical Quality Assurance
Core
Ensuring adherence to GLP and GCP regulations and developing an organizational model for the global Quality Assurance Unit for non-clinical studies.
Role type
Director, Preclinical Quality Assurance
Builds
Global Quality Assurance Unit operations and audit programs for non-clinical GLP/GCP regulated studies
Domain
Pharmaceutical R&D, Preclinical Research, Regulatory Compliance
Deliverable
infrastructure
Required skills
Global GLP regulations expertise, GCP laboratory requirements knowledge, Bioanalytical laboratory operations competence, Team management, Strategic planning, Risk assessment, Project management, Regulatory evaluation, Due diligence assessment, Performance management
Preferred skills
Accreditation by professional bodies (e.g., ASQ CQM/CQA), Membership in industry organizations (e.g., SQA, IQ Consortium)
Technologies
None stated
Responsibilities
Manage the Preclinical QA Team and Audit Program, Collaborate with GXP Vendor Compliance, Consult with Test Facility Management and Study Directors, Evaluate new regulatory requirements, Define quality goals for annual and long-range plans, Support Pre-Clinical Due Diligence activities, Conduct functional area management reviews, Define and execute personnel development plans
Seniority
Director, strategic leadership & team management