Job Descriptions

This Executive level, high impact position within the Quality organization will continue building a world class sterility assurance platform and environmental monitoring program supporting Bausch & Lomb . The person in this position will also provide expertise in Microbiology, Aseptic Manufacturing and Sterilization solving complex problems and influencing significant decisions impacting the company’s manufacturing operations. This person will lead the implementation of industry best practice, regulatory, guidance and standard requirements within processes and enhance systems.

The person will enhance, promote and implement a lab excellence programme across the vision care microbiology network. The role reports to an appointed Operational Quality executive committee member and will frequently interact with and make recommendations to senior leaders of the company.

• Enhance aseptic manufacturing, environmental manufacturing and facility/utility standards for Bausch & Lomb and Contract Manufacturing sites in partnership with the site quality functions.
• Direct microbiology, aseptic manufacturing and sterilization core competencies supporting vision care, product and process management programs.
• Work in partnership with R&D and technology engineering in product/process development phase to ensure design transfer includes assurance of sterility, robust environmental and aseptic programmes where applicable
• Establish a training program for manufacturing and laboratory personnel and international affiliates.
• Consult with all functions (R&D, Manufacturing, Quality, Regulatory, Commercial, and Legal) to solve microbiological, contamination control and product-related issues.
• Lead and participate on project teams that improve performance in aseptic manufacturing excellence & lab excellence programmes.

• Develop goals, objectives and plans for manufacturing operations staff involved in microbiology and sterilzation areas.

• Assist the compliance quality organisation in auditing environmental, sterility and environmental monitoring

Requirements

• BS degree in microbiology or related discipline; MS or PhD. degree preferred.
• Experience: Minimum of 10 years of experience in a manufacturing environment in an influential senior leadership role within a Quality organization with specific experience in controlled manufacturing environments , environmental monitoring and sterilisation principles and techniques  (e.g. Quality Manager, Director or Senior Technical Consultant).
• Must have demonstrated experience establishing environmental controlled manufacturing and facility/utility standards for a world class medical device organization.
• GMP expertise: EU, Asia, US and ISO.
• Risk management experience , Influencing , programme management
• Significant knowledge and experience in microbiology, sterilization and validation.
• Demonstrated track record of developing Quality systems, processes and programs across global regions.

Skills

• Communication Skills
• Project management
• People Management
• Management Skills
• Leadership Skills

Experience

• 10+