̽»¨ºÏ¼¯

̽»¨ºÏ¼¯ is seeking a Director of Vendor Compliance Management. This role is pivotal in developing and maintaining a risk-based vendor compliance strategy. The successful candidate will oversee the qualification process and ensure that quality assurance agreements are in place. This role also involves managing a global team. This position is based within London but can also be a fully remote role from within United Kingdom.

Responsibilities:

• Lead a team of Quality Assurance personnel located in various geographical locations.
• Maintain strong relationships with both internal and external stakeholders.
• Ensure adherence to departmental procedures and maintain inspection-ready documentation.
• Establish and maintain relevant Key Performance Indicators (KPIs).
• Support inspection activities upon request.
• Design and manage a proactive risk-based quality oversight strategy for vendors.
• Manage the vendor qualification process and maintain the vendor qualification database.
• Ensure vendor oversight post-qualification through quality assurance agreements, QA-QA calls, etc.

Key Skills and Requirements:

• Academic degree in Life Science is preferred, Masters degree or equivalent work experience is desired.
• Proven working knowledge in quality assurance within a monitored clinical environment.
• Experience in building and maintaining business partner relations.
• Robust experience in interpreting GCP guidelines for the pharmaceutical industry as they apply to vendors.
• Deep knowledge and experience in drug development, development of medical devices, clinical development, research operations, GCP, GLP, GPVP, GCP for Labs, general understanding of GMP.
• Knowledge and ability to apply process development expertise, industry standard problem-solving approaches, in alignment with Lean and Lean Six Sigma principles.
• Knowledge and experience in Inspection Readiness.
• Experience with due diligence, vendor qualification and vendor compliance oversight.
• Robust experience in worldwide regulations and guidelines (including ICH, FDA, EMA) related to clinical trial development and post-approval medicinal products.
• Proven leadership with teams, mentoring and guiding team members development.
• Strong experience in developing and maintaining a proactive, risk-based Vendor Quality Strategy.
• Computer literacy, including MS Office suite (Excel, PowerPoint, Office, etc.).
• Experience in a quality management system along with resource and budget planning.
• Strategic project development and project management.
• Ability to travel (at least 15%).

If you are having difficulty in applying or if you have any questions, please contact Josh Godden on j.godden@proclinical.com.

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

̽»¨ºÏ¼¯ is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. ̽»¨ºÏ¼¯ is acting as an Employment Agency in relation to this vacancy.