Job Summary

• This role is essential in ensuring that both internal sterility assurance standards and external regulatory standards and guidance are comprehensively understood and effectively applied throughout the organization.
• The Director also identifies business solutions to enhance aseptic and low bioburden manufacturing processes, aiming to improve robustness and efficiency while building strong internal and external relationships with key stakeholders.
• The main duty of this role is to facilitate interaction between Quality and various sites or departments for the implementation of Quality Management System (QMS) standards and continuous improvement initiatives, including KPI trending and capability development in sterility assurance domains and process confirmations.

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Skills & Requirements

Key Requirements

• Bachelor degree in a Scientific Discipline
• Significant experience in aseptic or bioburden control manufacturing
• In depth knowledge of regulations, guidance, best practices
• Strong technical and quality skills in sterility assurance
• Coaching and mentoring capabilities

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