̽»¨ºÏ¼¯

Early & Clinical Development Quality Lead

€135000 - €140000 per annum
  1. Permanent
  2. Good Pharmacovigilance Practice (GVP)
  3. Belgium
Braine-l'Alleud, België
Posting date: 03 Dec 2024
63427

̽»¨ºÏ¼¯ is seeking an Early & Clinical Development Quality Lead to join our Quality organization. This role will drive quality and compliance in the early, clinical development, and post-marketing phases of compounds globally. The successful candidate will ensure quality by design and continuous inspection readiness, with a focus on data integrity.

Responsibilities:

  • Develop and maintain a quality strategy and roadmap for assigned compounds.
  • Apply a risk-based approach to identify and manage quality risks.
  • Ensure compliance with GxP regulations and internal procedures.
  • Collaborate with internal and external partners for successful execution.
  • Plan, coordinate, and execute quality activities to ensure subject safety and data integrity.
  • Lead compliance investigations and follow up on corrective actions.
  • Support GLP/GCP/GVP inspection readiness and management.
  • Monitor system performance and data quality to inform key decisions.
  • Conduct analytics and qualitative assessments to identify trends.
  • Develop and maintain procedural documents related to quality activities.
  • Lead or support inspections and investigations by international authorities.
  • Provide input in risk assessment strategies for GxP audit programs.
  • Perform regulatory required audits and risk-based assessments.
  • Represent quality at interdepartmental and project team meetings.
  • Deliver presentations to peers, senior management, and industry audiences.

Key Skills and Requirements:

  • Bachelor's Degree in a relevant scientific or healthcare-related field.
  • Proficient in research/GLP, GCP, and/or GVP regulations.
  • Ability to translate regulatory and quality expectations into operations.
  • Expertise in Neurology, Immunology, and Advanced Therapeutic Medicinal Products preferred.
  • Experience in quality auditing, inspection, or compliance management is an asset.


If you are having difficulty in applying or if you have any questions, please contact Josh Godden at 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.

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