QA CSV Program Lead - GxP Validation & Compliance

MindCapture; Antwerpen; Sur place; EUR 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Meal vouchers

Eco vouchers

DKV health insurance

Group insurance

Net expense allowance

Company car

Training & development

Résumé du poste

MindCapture is seeking a QA CSV Program Lead to drive a major digital manufacturing transformation for a strategic healthcare project. You will lead validation governance for manufacturing systems and ensure GxP compliance across the project lifecycle.

As a senior QA CSV leader, you will review validation docs, manage risk-based validation activities, mentor teams, and coordinate with IT, Engineering, Manufacturing and Quality to ensure readiness for audits and inspections.

Qualifications

• Bachelor or Master degree in Engineering, Computer Science, Life Sciences, Pharmacy, Biotechnology or related discipline.
• Minimum 10 years of Computer System Validation experience in regulated pharma/biotech/medical devices.
• Minimum 5 years in a QA CSV leadership or validation governance role.
• Strong experience with GxP manufacturing systems, MES or automation environments.
• Excellent knowledge of GAMP 5, EU GMP Annex 11, 21 CFR Part 11 and Data Integrity.
• Experience with validation lifecycle management, change control, deviations and CAPAs.
• Experience working in global matrix project organisations.
• Experience supporting audits and regulatory inspections.
• Experience with MES platforms such as PAS X, PharmaSuite, Syncade or similar is an advantage.
• Strong stakeholder management, leadership and quality decision making skills.

Responsabilités

• Act as the QA CSV Lead for a large scale manufacturing system implementation.
• Define and maintain the validation strategy for manufacturing systems, infrastructure, interfaces and automation.
• Ensure compliance with GxP requirements, GAMP 5, EU GMP Annex 11, 21 CFR Part 11 and Data Integrity principles.
• Provide QA oversight throughout design, testing, deployment, go live, hypercare and operational handover.
• Lead validation governance using a pragmatic, risk based approach.
• Review and approve validation documentation, risk assessments, testing documentation, deviations, CAPAs and lifecycle deliverables.
• Represent QA CSV within project governance and quality decision forums.
• Support deployment readiness, release readiness and inspection readiness across multiple implementation phases.
• Embed Data Integrity throughout validation activities and system lifecycle management.
• Oversee validation testing, defect management and qualification activities.
• Act as the subject matter expert during audits and regulatory inspections.
• Collaborate with Digital, IT, Engineering, Manufacturing, Automation, Quality and cross functional project teams.
• Mentor project team members on validation and compliance expectations.

Connaissances

Leadership

Stakeholder management

Quality decision making

Regulatory compliance

Formation

Bachelor or Master degree in Engineering, Computer Science, Life Sciences, Pharmacy, Biotechnology

Outils

PAS X

PharmaSuite

Syncade

Description du poste

MindCapture is seeking a QA CSV Program Lead to drive a major digital manufacturing transformation for a strategic healthcare project. You will lead validation governance for manufacturing systems and ensure GxP compliance across the project lifecycle.

As a senior QA CSV leader, you will review validation docs, manage risk-based validation activities, mentor teams, and coordinate with IT, Engineering, Manufacturing and Quality to ensure readiness for audits and inspections.