Site QA & Regulatory Conformance Expert - Life Sciences

Capgemini; Diegem; Sur place; EUR 45 000 - 55 000; Plein temps

Résumé du poste

Capgemini Belgium (Diegem) seeks a Site Conformance Expert to ensure regulatory compliance across Manufacturing, Quality Control and Materials streams. The role interfaces with operations and regulatory affairs to maintain alignment with evolving standards.

You should have a Master’s in Pharmaceutical Sciences or related field and at least 3 years in QA within pharma. Strong GMP knowledge and experience with eCTD are required. Fluent English and French are preferred for stakeholder collaboration.

Qualifications

• Master's degree in a relevant field and 3+ years in QA within pharma or life sciences.
• Strong knowledge of GMP and regulatory requirements including eCTD.
• Experience coordinating with cross-functional teams to maintain quality systems.

Responsabilités

• Ensure regulatory dossiers and health authority responses are timely and accurate.
• Provide regulatory oversight across Manufacturing and QC to align with current standards.
• Identify compliance gaps and devise mitigation to prevent supply issues or recalls.
• Collaborate with teams to implement and maintain global quality systems.

Connaissances

GMP knowledge

Regulatory compliance

Cross-functional

Attention to detail

Regulatory documentation

Formation

Master's in Pharmaceutical Sciences

Outils

eCTD

Description du poste

Capgemini Belgium (Diegem) seeks a Site Conformance Expert to ensure regulatory compliance across Manufacturing, Quality Control and Materials streams. The role interfaces with operations and regulatory affairs to maintain alignment with evolving standards.

You should have a Master’s in Pharmaceutical Sciences or related field and at least 3 years in QA within pharma. Strong GMP knowledge and experience with eCTD are required. Fluent English and French are preferred for stakeholder collaboration.