Head of Global Clinical and Safety Quality Compliance

hace 2 semanas


Puerto Diablo Barrio, Puerto Rico Biospace, Inc. A tiempo completo

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:

  1. Provides quality oversight of the quality systems supporting clinical research, pharmacovigilance, and medical activities across the enterprise.
  2. Ensures the quality systems are robust, aligned with and compliant to applicable regulatory requirements.
  3. 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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