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Head of Global CMC Compliance

2 months ago

London, Greater London, United Kingdom Fraser Dove International Full time
About the Role

We are seeking a highly experienced and skilled professional to lead our Global CMC Compliance function. As the Head of Global CMC Compliance, you will be responsible for ensuring regulatory compliance of all medicinal products and medical devices with applicable guidelines, regulations, and approved authorizations.

Key Responsibilities
  • Develop and implement strategic initiatives to enhance global CMC compliance and drive continuous improvement across all quality processes.
  • Lead and develop a global team, fostering a culture of continuous improvement and operational excellence.
  • Ensure regulatory compliance for all medicinal products and medical devices, in line with guidelines, regulations, and approved authorizations.
  • Manage the change control process and ensure timely and efficient creation of regulatory documentation for dossiers.
  • Determine CMC-regulatory strategy and ensure QA oversight over due diligence and post-merger integrations.
  • Support the preparation of GMP documents, such as PQRs, technical agreements, manufacturing instructions, and validation protocols.
  • Recruit, coach, and develop the Global CMC Compliance team, while managing resources and supporting career development.
  • Plan and monitor the budget for Global CMC Compliance.
  • Support cross-departmental projects focused on operational excellence and business development.
  • Assist the Head of Global Quality Assurance with strategic definition and planning, as well as leading special projects.
Requirements
  • Strong leadership skills, including feedback capabilities to motivate and develop a diverse, global team.
  • A global and service-oriented mindset with a strong sense of cultural diversity.
  • The ability to prioritize and manage multiple complex projects, ensuring critical deadlines are met.
  • Experience in continuous improvement and process excellence, with a focus on driving efficiency gains.
  • University degree, preferably in Pharmacy, with several years of experience in Quality Assurance, Regulatory Compliance, and/or Regulatory Affairs in pharmaceutical companies.
  • Profound knowledge of CMC dossiers, regulatory requirements, and quality documentation for medicinal products.
  • Several years of experience leading and developing teams of approximately 20 people across different time zones and cultures.
  • Expertise in process improvement, with experience using OPEX, Kaizen, LEAN, and other continuous improvement tools.
  • Fluent in German and English.