Position Details
About this role
Associate Director, Clinical Quality Assurance leads proactive quality oversight of clinical development programs, ensuring GxP compliance and inspection readiness while coordinating audits and building robust QA processes across R&D.
Key Responsibilities
- Lead collaboration across TAs to ensure best practices; Lead cross-functional projects and strategies; Monitor new regulations and ensure compliance; Coordinate internal and external compliance actions and audits; Lead risk management and QA communications
Technical Overview
Role emphasizes QA leadership in clinical development environments, with focus on GxP compliance, regulatory affairs, audits, validation, and cross-functional collaboration.
Ideal Candidate
The ideal candidate is a senior QA/Regulatory affairs executive with 10+ years in pharma, leading cross-functional clinical QA initiatives, ensuring inspection readiness and regulatory compliance across R&D and manufacturing.
Must-Have Skills
Nice-to-Have Skills
Required Skills
Hard Skills
Soft Skills
Certifications
Preferred
Industry & Role
Keywords for Your Resume
Deal Breakers
Lack of 10+ years pharma QA/regulatory experience, No experience with GxP systems or regulatory audits, Inability to lead cross-functional teams
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