Proclinical 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.

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.