QA Validation Manager

il y a 2 semaines

Bruxelles, Région de Bruxelles, Belgique BioTalent Temps plein

A leading global biopharmaceutical company is seeking a QA Validation Manager to support a brand-new facility who are moving into commercial manufacturing this year.

You will be responsible for leading and overseeing all aspects of quality assurance validation activities within the manufacturing facility, ensuring compliance with regulatory standards by qualifying and validating equipment, processes, and utilities.

This role will offer you:

  • The chance to work in a forward-thinking environment.
  • To be part of a dynamic, supportive, and collaborative environment where your growth and development will be a priority.
  • To lead transformative projects, shape the future of biomanufacturing, and contribute to producing medicines that truly improve lives.
  • The opportunity for significant growth within a pioneering, global biotech company.

Responsibilities:

  • Lead and manage the validation activities within the Quality Assurance department, ensuring compliance with GMP regulations and company policies.
  • Oversee validation programs for equipment, facilities, utilities, and computerized systems to ensure operational excellence.
  • Provide strategic direction for validation procedures, risk assessments, and process improvements.
  • Collaborate closely with cross-functional teams, including manufacturing, engineering, and regulatory affairs, to support validation projects.
  • Conduct internal and external audits, ensuring adherence to industry and regulatory standards.
  • Act as a subject matter expert for validation-related topics, providing guidance and training to the team.
  • Drive continuous improvement initiatives to enhance validation practices and maintain compliance with evolving regulatory requirements.

Skills & Experience Required:

  • Strong background in Quality Assurance and Validation within a GMP-regulated pharmaceutical or biotechnology environment.
  • Extensive experience in validation of equipment, facilities, utilities, and computerized systems.
  • In-depth knowledge of regulatory requirements such as EU GMP, FDA, and ICH guidelines.
  • Strong leadership and project management skills, with the ability to influence and drive change.
  • Excellent problem-solving skills and the ability to manage multiple projects simultaneously.
  • English & French language skills

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