Applyđź“Ť United States
🧠Full-Time
đź’¸ 225000.0 - 260000.0 USD per year
🔍 Biopharmaceutical
- 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.
- 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.
LeadershipGCPQuality AssuranceProcess improvement
Posted about 2 months ago
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