QP Delegate

Sanofi; Geel; On-site; EUR 80,000 - 110,000; Full time

Job summary

Sanofi Geel seeks a QP Delegate to support the Qualified Person in batch release for clinical and commercial products. You will review dossiers, approve COA/CoC, and ensure compliance within the site quality system.

Requirements include a Master of Industrial Pharmacy, a valid QP number, 8–10 years in pharma, and fluency in Dutch and English. Based in Geel, Belgium with focus on biotechnology processes.

Qualifications

• Master of Industrial Pharmacy is required.
• Valid QP number recognized by Belgian Minister of Health is required.
• 8–10 years in the pharmaceutical industry; biotechnology production knowledge.
• Fluency in Dutch and English is required.

Responsibilities

• Acts as key QA representative for batch release decisions.
• Reviews and approves batch release dossiers and related certificates.
• Manages deviations, change controls and regulatory submissions impact.
• Oversees analytical batch abstracts and drug substance specifications.

Skills

QA & compliance

Batch release

Biotech knowledge

Education

Master of Industrial Pharmacy

Tools

QP certification

Job description

QP Delegate

Locatie: Geel

Level: L2-2

Hiring manager: Gunter Aerts

About the Role

The QP Delegate serves as a key quality assurance representative, supporting the Qualified Person (QP) in ensuring compliance with regulatory requirements and internal quality standards for the release of commercial and clinical batches. While the QP delegate has the responsibility for approving the batch release dossier based on a detailed review of the batch release dossier content, the QP delegate relies on the pharmaceutical quality system of the site under the responsibility of the Qualified Person.

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 !

Pursue progress , discover extraordinary

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 !

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.