Head of Quality

  • Location

  • Salary

  • Job Type

  • Functions

    Quality Assurance

Scienta are teaming up with a leading large molecule biotech, with a Global presence in the look for their new Head of Quality. Are you up for the challenge?

Main responsibilities –

  • Leadership of the Quality Assurance and Quality Control departments within the Quality organisation.

  • Holder of the role as Head of Quality Assurance for the production sites for biological finished medicinal products and biological active pharmaceutical ingredients.

  • Development and implementation of the overall quality strategy, in line with the strategic business plans, the global production strategy, and the corporate quality strategy.

  • Responsible for budget, personnel planning, project work, meeting deadlines, personnel management and development, target agreements and the success of the department.

  • Oversee site quality processes such as manufacturing, product release, process quality, quality control, quality systems, qualification, and validation. Establish and monitor quality metrics.

  • Ensure that the sites’ quality standards, practices, procedures, and documentation comply with cGMP regulations, pharmacopoeias, global, regional, and site-specific requirements of the company, as well as required industry standards.

  • Drive the development, implementation, and improvement of the Pharmaceutical Quality Management System (PMS) for the manufacturing sites as part of continuous improvement.

  • Lead the preparation and execution of regulatory inspections and customer audits. Maintaining the state of inspection readiness.

Your profile:

  • At least 15 years relevant work experience in quality including 10 years of managerial experiences and 15 years of experience in pharmaceutical industries. Experience in Biologics is preferable.

  • Advanced degree (Bachelor, Master or PhD) in Chemistry, Biochemistry, Microbiology, Molecular Biology, Biological Engineering, or another related field.

  • Very good knowledge of EMA & FDA regulations, and ICH & WHO guidelines.

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