Senior Manager Sterility Assurance

Responsibilities

• Responsible for sterility assurance business site projects presenting high complexity, including implementation and qualification of new filling lines and engineering changes to the facility
• Develops the sterility assurance project strategy, scope and objectives, involving all relevant stakeholders, and ensuring technical feasibility
• Predict and manage resources needed to reach project objectives, monitor project progress, timeline, and budget tracking
• Leads/coordinates complex project related deviations, reporting of product technical complaints and implementation of remedial actions
• Supports preparation, successful conduct and follow-up of regulatory inspections, self-inspections and customer audits as required
• Responsible for the generation and review of the documentation Qualifications
• Bachelor's degree in Microbiology, Biology, Chemistry, Biochemistry, or life sciences or equivalent relevant field; advanced degree preferred
• 7+ years' experience in pharmaceutical manufacturing industry and GMP experience in pharmaceutical, biotech, or other regulated industry
• Experience interacting with regulatory authorities including submissions and inspections; knowledge of auditing practices and procedure
• Experience within a global matrix organization
• Demonstrated success in project management and business/QA systems
• Knowledge of appropriate regulatory requirements including GMP/GQP Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.