QP consultant

• Serve as the primary QP contact point for operational issues in a defined manufacturing area.
• Provide QP-related guidance to QA engineers during early involvement meetings and identify deviations or changes requiring escalation to the QP Governance meeting.
• Perform detailed review and approval of batch release dossiers and Certificates of Analysis (CoA).
• Execute release of commercial and clinical lots in the ERP system for shipment to Drug Product sites.
• Review and approve deviations requiring QP involvement, as well as new submissions or major updates to regulatory filings.
• Approve Product Specification Sheets, export certificates for US-bound product samples, and shipments to Sanofi or partner sites outside existing agreements.
• Oversee and approve the exceptional use or destruction of site reference/reserve samples, and authorize requests to supply reserve samples to health authorities.

Out of Scope: Legal certification of batches in the release register (vrijgaveregister).

Candidate Profile:

• Education: Master of Industrial Pharmacy.
• Legal Status: Mandatory registration number on the official list of Qualified Persons (Articles 84 and 211 of the Royal Decree of 14 December 2006).
• Experience: Minimum 8–10 years in the pharmaceutical industry, ideally with prior experience acting as a QP, combined with comprehensive expertise in biotechnology production processes.
• Languages: Professional fluency in Dutch and English (spoken and written).

Hiring Context: Direct replacement role (skills-based hiring not enabled).