QP Delegate

Sanofi Group; Geel; On-site; EUR 120,000 - 150,000; Full time

Job summary

Sanofi Geel is seeking a QP Delegate (Location: Geel) to oversee quality and batch release activities. You will act as the primary QP contact for quality issues, review and approve batch release dossiers, and manage certificates of analysis/conformity.

Key responsibilities include QP governance, deviations/change controls with regulatory impact, and approvals of analytical specs for products. Fluent Dutch and English are essential; Master of Industrial Pharmacy and a valid QP number are required.

Qualifications

• Master of Industrial Pharmacy is required.
• Valid QP number and QP initial training must be kept up to date.
• 8–10 years of pharmaceutical industry experience; QP experience preferred.
• Fluency in Dutch and English is required.

Responsibilities

• Acts as the first QP contact point for quality-related issues.
• Reviews and approves batch release dossiers and Certificates of Analysis/Conformity.
• Manages ERP Usage Decisions for Sanofi Geel batches.
• Provides QP feedback during involvement meetings and escalation as needed.
• Reviews deviations/change controls requiring QP involvement; approves retest plans.
• Approves analytical batch abstracts and Drug Substance Specification Sheets.
• Reviews Periodic Product Review and approves shipment of samples when required.
• Approves use or destruction of reference samples and regulatory sample requests.

Skills

Quality systems

Biotech production

QA collaboration

Dutch language

English language

Education

Master of Industrial Pharmacy

Valid QP number

Job description

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-0037724.
• 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 www.sanofi.com 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 communities. This is where you grow your career. We open the door for you to explore new opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people’s lives.