Head of Global Clinical and Safety Quality Compliance
hace 2 semanas
Job Title: Head of Global Clinical and Safety Quality Compliance
About the role:
Leads the global Clinical, Pharmacovigilance, and Medical Quality Compliance organization, providing quality oversight of the quality systems supporting clinical research, pharmacovigilance, and medical activities across the enterprise.
Main Responsibilities:
- Provides quality oversight of the quality systems supporting clinical research, pharmacovigilance, and medical activities across the enterprise.
- Ensures the quality systems are robust, aligned with and compliant to applicable regulatory requirements.
- Serves as a senior strategic Quality Partner to various Compliance functions in Data Science Institute, Global Development Operations, and Global Regulatory Affairs.
Requirements:
- Scientific or allied health/medical degree (BSc). Masters/PhD preferred.
- Minimum of 15 years of increasing responsibility and relevant experience in the global pharmaceutical industry, preferably with at least 5 years of Quality/Compliance experience.
- Advanced knowledge of clinical research, pharmacovigilance, and medical throughout R&D and commercialization, and relevant regulations.
Additional Information:
This role requires a strong background in quality and compliance, with experience in strategic roles involving quality systems and clinical portfolio oversight, large-scale audit programs, regulatory inspection management, investigation and remediation activities on a global level, and successful management of business transformation/change management initiatives.
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