Senior Director Quality Assurance
About The Position
The Senior Director, Quality Assurance is a senior leadership role responsible for defining, implementing, and continuously improving the organization’s global Quality Management System (QMS) to ensure compliance with regulatory, client, and internal standards. This role provides strategic oversight of quality assurance across all clinical and operational activities, ensuring inspection readiness, audit excellence, and a proactive quality culture aligned to business growth objectives. The position operates as a key member of the leadership team, partnering cross-functionally to enable compliant delivery, client confidence, and sustainable business performance.
Requirements
- Degree in Life Sciences, Pharmacy, or related discipline
- 15+ years’ experience within CRO / pharmaceutical / clinical research environments
- Extensive experience in QA leadership roles within regulated environments
- Deep working knowledge of global GxP, ICH-GCP, and regulatory frameworks
Nice To Haves
- Advanced degree (MSc, PhD) or relevant QA certification
- Experience leading global QA functions across multiple regions
- Demonstrated regulatory inspection leadership experience (FDA, EMA, etc.)
Responsibilities
- Establish and lead the global QA strategy aligned to organizational growth, regulatory expectations, and client requirements
- Own and maintain the Quality Management System (QMS), ensuring scalability across geographies and service lines
- Lead the global audit program across investigator sites, vendors, systems, and internal processes
- Ensure continuous inspection readiness for regulatory authorities and client audits
- Ensure compliance with global GxP standards and applicable regulatory requirements
- Monitor regulatory landscape and proactively adapt QA practices
- Identify and implement process improvements to enhance delivery quality, efficiency, and scalability
- Leverage data and analytics to identify quality trends and systemic improvement opportunities
- Partner with Business Development and Delivery teams to support client proposals and due diligence activities
- Provide QA leadership in client engagements, audits, and escalations
- Build, lead and develop a high-performing global QA team
- Ensure capability development, succession planning, and workforce scalability
- Own QA budget and resource allocation to ensure efficient and scalable delivery
Benefits
- flexible working options
- paid parental leave for both parents
- flexible leave entitlements
- wellness programs
- ongoing development programs
- mentorship opportunities
- professional development programs
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What This Job Offers
Job Type
Full-time
Career Level
Director
