Position Details
About this role
Associate Director, Clinical Quality Assurance is responsible for proactive quality oversight of clinical development programs, ensuring regulatory compliance and inspection readiness across AbbVie RDQA functions.
Key Responsibilities
- Lead collaboration across TAs to ensure best practices and lessons learned are applied; Lead cross-functional projects and strategies across Therapeutic Areas; Monitor new regulations and industry trends; Identify and manage issues, escalate as needed; Ensure inspection readiness and actionable QA insights
Technical Overview
Leads QA strategies for clinical development, emphasizes GCP/GxP compliance, regulatory liaison, risk management, and CAPA-driven improvement; manages document control and quality system elements.
Ideal Candidate
The ideal candidate is an experienced clinical QA leader with a strong background in GCP/GxP, regulatory affairs, and inspection readiness to ensure compliance across clinical development programs.
Must-Have Skills
Nice-to-Have Skills
Required Skills
Hard Skills
Soft Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
no bachelor’s degree in a relevant science or healthcare field, less than 10 years of pharmaceutical QA/regulatory experience, unwillingness to be on-site in South San Francisco
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