Head of Quality

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.