Global Manufacturing Validation Lead — GMP/Regulatory Expert

Akkodis; Antwerpen; Sur place; EUR 70 000 - 100 000; Plein temps

Résumé du poste

Akkodis is seeking a Manufacturing Validation Lead in Belgium to oversee validation activities across the product lifecycle, including plans, protocols, risk assessments and reports. The role ensures compliance with GMP, GDP and global standards, collaborating with cross-functional teams and external CMOs.

You will act as a Validation SME for regulatory submissions and inspections, driving quality and continuous improvement within FUE, Process Validation and Comparability initiatives.

Qualifications

• Proven ability to communicate in Dutch and English, both written and verbal.
• Strong cross-functional collaboration across teams and functions.
• Experience in project management within validation projects.
• Sound decision-making, negotiation and problem-solving skills.
• GxP quality systems understanding (GMP, GDP, ISO13485, MDSAP).
• Hands-on expertise in equipment qualification and validation workflows.

Responsabilités

• Create, review, approve, and execute validation plans, protocols, risk assessments and reports for transport and process validation.
• Review CMOs’ qualification/validation data and reports for completeness.
• Assess validation impact from change controls, deviations, audits and CAPAs.
• Support CPV protocols, APQR and Control Process Validation studies.
• Serve as validation SME for regulatory submissions, health authority questions and inspections.
• Ensure validated processes comply with GMP/GDP and CMOs' requirements.
• Contribute to COP activities by sharing best practices and roadmap input.

Connaissances

Dutch/English comms

Cross-functional collab

Project management

Decision making

GxP knowledge

Equipment qualification

Description du poste

Akkodis is seeking a Manufacturing Validation Lead in Belgium to oversee validation activities across the product lifecycle, including plans, protocols, risk assessments and reports. The role ensures compliance with GMP, GDP and global standards, collaborating with cross-functional teams and external CMOs.

You will act as a Validation SME for regulatory submissions and inspections, driving quality and continuous improvement within FUE, Process Validation and Comparability initiatives.