Sr. Director, Clinical Quality Assurance

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Requirements:

• Demonstrated expertise in guiding the development of the Quality Management System.
• Ability to build relationships and collaborate effectively.
• Strong negotiation skills and flexibility in a solution-based approach.
• Capable of managing multiple projects and time demands efficiently.
• Bachelor's degree in a scientific discipline or equivalent experience.
• Minimum of 8 years of experience in a GCP practice area, preferably Clinical Quality Assurance.
• Expertise with applicable GCP guidelines.
• Experience with Veeva platform is highly preferred.

Responsibilities:

• Lead the development and maintenance of Clinical aspects of BBGT’s Quality Management System.
• Support inspection readiness and audits by external sources.
• Manage direct reports and consultants to meet clinical quality objectives.
• Coordinate documentation of quality events and corrective actions.
• Provide Clinical Quality Assurance leadership to clinical study teams.
• Author and maintain QA Standard Operating Procedures (SOPs).
• Support training oversight in collaboration with functional leads.
• Lead process improvement projects as necessary.
• Conduct internal and external service provider audits.