Director, Vendor Compliance Management

Proclinical 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.

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