Senior Validation Lead — GMP Compliance & Strategy

Akkodis

Waals-Brabant

On-site

EUR 85,000 - 110,000

Full time

32 hours ago
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Job summary

Akkodis is seeking a Senior Validation Team Leader in Belgium to lead a validation group within the pharmaceutical/biopharmaceutical sector. You will shape validation strategy, supervise multidisciplinary activities and ensure adherence to GMP and regulatory guidelines.

You will review validation documents, manage deviations and CAPA, and coordinate cross-functional teams to deliver validated state across projects. Fluency in French, English, or Dutch is an asset.

Qualifications

  • Master’s degree in a relevant scientific field.
  • 5–8 years of validation experience in pharma/biopharma.
  • Experience leading or coordinating a validation team.
  • Strong knowledge of GMP, deviation management, CAPA and change control.
  • Fluency in French, English and/or Dutch is an asset.

Responsibilities

  • Lead and coordinate the validation team, ensuring effective planning and execution of validation activities.
  • Define and implement the validation strategy in accordance with GMP requirements and regulatory guidelines.
  • Oversee process validation, cleaning validation, analytical method validation and computerized system validation, depending on project scope.
  • Review and approve validation protocols, reports, risk assessments and technical documentation.
  • Ensure compliance with GMP, regulatory standards and internal quality procedures.
  • Supervise deviation investigations, CAPA implementation and change control processes.
  • Coordinate cross-functional activities with QA, QC, Production, Engineering and Regulatory Affairs.
  • Monitor project progress, timelines, resources and deliverables.
  • Provide technical guidance, coaching and support to validation engineers.
  • Act as the main point of contact for validation-related matters during audits and regulatory inspections.
  • Drive continuous improvement initiatives and ensure the maintenance of the validated state.

Skills

Team leadership
Validation strategy
GMP compliance
Deviation management
CAPA
Change control
Risk-based approaches
Stakeholder coordination
Audits
Prioritization & multitasking

Education

Master’s degree in Engineering/Biotechnology/Cir Chemistry/Pharmacy or related

Job description

Akkodis is seeking a Senior Validation Team Leader in Belgium to lead a validation group within the pharmaceutical/biopharmaceutical sector. You will shape validation strategy, supervise multidisciplinary activities and ensure adherence to GMP and regulatory guidelines.

You will review validation documents, manage deviations and CAPA, and coordinate cross-functional teams to deliver validated state across projects. Fluency in French, English, or Dutch is an asset.

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