Site Leader Sterility Assurance (m/f/x) R-279328

Site Leader Sterility Assurance (m/f/x) R-

Internal job title: Site Leader Sterility Assurance w/ direct reports

Reporting into the Director of QA for Filling & Sterility Assurance, the Site Sterility Assurance Lead will be responsible for the leadership, oversight and life cycle management for the contamination control governance elements.

Arbeitsort

Marburg

Skill Categories

• Biologe/Biologin
• Pharmazeut/in
• Chemiker/in

The Opportunity

• The role holder is responsible for the local sterility assurance team, prioritisation, organisation and communication of workload and issues/resolutions to through appropriate forums and representation of the Manufacturing Site at a regional and global level.
• Provide strategic leadership to the site related to Sterility Assurance standards, culture and continuous improvement.
• Partner closely with the Quality leadership team as well as partner functions, develop strategies to ensure continuous adherence to regulatory and CSL standards related to Sterility assurance governance and drive improvements.
• Provide oversight of quality standards and systems aligned with the Sterility Assurance function.
• Set objectives and provide clear direction for execution within area of responsibility.
• Implement and drive a learning culture and ensure a vertical and horizontal knowledge management.
• Partner closely with their peers in Global and Local Sterility Assurance from the other manufacturing sites and ensure that the same principles and systems are applied across all CSL Enterprise manufacturing sites to drive standardization on operational level and within capital projects.

Your Skills and Experience

• Bachelor’s degree in a related discipline (Microbiology, Biochemistry, Pharmaceutical Sciences). Advanced degree (Masters/Ph.D) preferred.
• Broad and proven experience in leading teams within matrix organizations, collaborating effectively with both global and local stakeholders
• +7 years of experience in the pharmaceutical manufacturing industry
• Demonstrated strong technical knowledge in the areas of sterility assurance of aseptic cleanroom facilities, their processes and equipment, to include design, validation and monitoring, life cycle management and cGMP compliance.
• Demonstrated experience in quality assurance and regulatory compliance with GxP, FDA, EU and other regulatory agency guidelines.
• Knowledge of auditing practices and procedures
• Excellent verbal and written communication skills in the local language and English with the ability to effectively present within all levels of the organization, with external colleagues and collaborators and regulatory agencies

We are looking forward to your application. Please ensure to apply online with your CV and certifications as well as your salary expectation.