Early & Clinical Development Quality Lead
- Permanent
- Good Pharmacovigilance Practice (GVP)
- Belgium
̽»¨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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