Job Description
PE Global is currently recruiting for a Director Clinical Processes & Solutions for an 18 month contract role with a leading multinational Pharma client based in London.
The Director Clinical Processes & Solutions, in close collaboration with Process, Risk & Surveillance (PRS), is accountable for the CD end-to-end processes, related Standard Operating Procedures, in alignment with regulations, and leading a cross-functional/cross-divisional network of Subject Matter Experts to continuously drive process improvement and inspection readiness on behalf of Global Drug Development.
Job Responsibilities
1. Drives cross-CD and Global Line Function alignment of processes, including implementation across Development Units, to ensure high-quality processes and limited inspection findings.
2. In partnership with Development, CD, PRS, Global Clinical Operations, Regulatory Affairs, and Quality Assurance, ensures processes are in line with regulatory requirements and inspection findings adequately addressed.
3. In collaboration with QA, responsible to implement quality initiatives as needed: inspection readiness, records tracking, support audits preparation and follow up. Presents applicable CD processes to Health Authority inspectors and auditors.
4. Establishes and maintains a multi-disciplinary network composed of Subject Matter E...