QP Delegate

About the Role

QP Delegate Locatie: Geel Level: L2-2 Hiring manager: Gunter Aerts

Key Responsibilities

Quality & Batch Release

• Acts as the first QP contact point for quality-related issues
• Performs detailed review and approval of batch release dossiers
• Reviews and approves Certificates of Analysis / Certificates of Conformity
• Changes the Usage Decision in the ERP system for Sanofi Geel commercial and clinical (F)DS batches

QP Governance & Escalation

• Provides QP-related feedback to QA Engineers during early QP involvement meetings
• Identifies deviations and/or changes requiring escalation to the QP Governance meeting

Deviations & Change Control

• Reviews and/or approves deviations and/or change controls (with regulatory and/or quality impact) where QP (Delegate) involvement is required
• Approves the retest plan of OOS results
• Reviews and/or approves new or major updates to regulatory submissions

Analytical & Product Specifications

• Approves the analytical batch abstract for Sanofi Geel QC testing of clinical/commercial products manufactured on (or under the responsibility of) other Sanofi sites
• Approves (Formulated) Drug Substance Specification Sheets

Product Review

• Reviews Periodic Product Review

Shipment & Export

• Approves shipment of product (samples) to Sanofi sites or Partner sites for purposes other than per existing agreements

Reference Samples

• Approves the usage (in exceptional cases) and/or destruction of Sanofi Geel Reference ('reserve') samples
• Approves the request to provide Reference ('reserve') samples to regulatory agencies

About You

• Education: Master of Industrial Pharmacy
• Certification: Valid QP number - recognized by the Belgian Minister of Health as Qualified Person as published in the Belgian official journal. QP initial training must be completed and kept up to date as described in QU-SOP- .
• Experience: Minimum 8–10 years in the pharmaceutical industry; prior experience as a QP is strongly preferred; extensive knowledge of and experience in biotechnology production processes.
• Languages: Fluency in both Dutch and English is required

Pursue Progress. Discover Extraordinary. Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science.

The salary range for this position is :€0,00 - €0,00 Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors.

Employees may be eligible to participate in Company employee benefit programs.

We are an R&D driven, AI-powered biopharma company committed to improving people’s lives and creating compelling growth.

Our team is guided by one purpose: we chase the miracles of science to improve people’s lives.

We want to build a healthier, more resilient world, and turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world.

Discover more about us visiting or via our movie We are Sanofi Start a career that makes a difference.

Reinvention is in our DNA. It’s what drove our evolution from a small French enterprise to one of the world’s leading biopharma companies. Whether it’s using AI to shorten drug-discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and com