Our client, a leading biotech company, is seeking a Head of Process Validation to lead validation activities for clinical and commercial cell therapy manufacturing in Belgium.
Responsibilities
Oversee all process validation activities, ensuring compliance with GMP and regulatory requirements.
Lead a team of process validation engineers, driving best practices in CAR-T manufacturing.
Develop and implement validation strategies, author key validation documents, and support regulatory submissions.
Serve as a validation SME for audits, process improvements, and investigations.
Collaborate with internal and external stakeholders to align validation strategies globally.
Requirements
Master’s degree in Engineering, Science, or related field.
10+ years of experience in biologics tech transfer and process validation, ideally in cell/gene therapy.
Strong leadership experience.
Deep knowledge of GMP, biotherapeutics process validation, and regulatory requirements.