Evidence Quality Lead

Step into a leadership role where your expertise in evidence quality supports innovation, compliance, and successful global product launches.

Proclinical is seeking an Evidence Quality Lead to join a dynamic team dedicated to ensuring compliant Research, Development, and Pharmacovigilance processes. This role focuses on embedding quality by design, maintaining continuous inspection readiness, and supporting successful global product launches.

Responsibilities:

• Develop and maintain a quality strategy at the compound level, covering clinical development and post-marketing phases.
• Identify and manage risks using a risk-based approach across compounds, processes, systems, sites, and vendors.
• Ensure compliance with GxP regulations and internal procedures while streamlining complexity.
• Plan and execute quality activities independently to ensure subject safety and data integrity.
• Lead compliance investigations and oversee timely closure of corrective and preventative actions.
• Escalate issues early and ensure effective resolution or mitigation measures are in place.
• Manage pre-inspection documentation reviews and collaborate with functional SMEs and global process owners.
• Conduct analytics and qualitative assessments to identify trends and monitor vendor performance.
• Lead or support inspections and investigations, coordinating responses and hosting strategies.
• Provide expert advice on GxP legislation updates and assess their impact on procedures and systems.
• Deliver presentations to peers, senior management, and industry audiences.

Key Skills and Requirements:

• Advanced degree in a relevant scientific or healthcare-related field.
• Strong understanding of quality principles and ability to translate regulatory expectations into operations.
• Experience in GLP, GCP, and/or GVP quality auditing, inspection compliance, or medical device regulations is advantageous.
• Skilled in collaboration, engagement, and influencing within a global matrix organization.
• Proficient in prioritizing critical issues using a risk-based approach.
• Strong analytical skills with the ability to synthesize complex data.
• Fluent in English (oral and written); additional languages are a plus.
• Experience working within the ATMP regulatory framework is preferred.
• Ability to manage quality and compliance issues with diligence, transparency, and timeliness.
  

If you are having difficulty in applying or if you have any questions, please contact Ingrid Wilson at i.wilson@proclinical.com.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists 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.

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