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Senior Director, GCP Quality Assurance
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Full-time
- The Senior Director, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, Sample Management and Pharmacovigilance as well as vendors supporting Scholar Rock sponsored Clinical Studies.
- This is a high visibility role and will be directly involved in development and continuous improvement of GCP Quality and overall Quality Management Systems at Scholar Rock as we grow and mature organizationally.
- This individual will be responsible for coordinating with key stakeholders to develop/implement processes and systems governing GCP activities and will report into the Vice President of Quality Assurance.
- Reporting to the Head of Quality Assurance, the Director/Sr. Director, Clinical Quality Assurance (CQA) is responsible for the development and implementation of processes and programs that provide quality and compliance oversight utilizing proactive end to end strategies for all clinical development programs, and pharmacovigilance activities.
- The incumbent builds collaborative, supportive relationships and serves as the single point of accountability for Quality Assurance across all clinical development programs including Clinical Operations, Pharmacovigilance, Data Management, Biometrics and other relevant stakeholders.
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