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.
#J-18808-Ljbffr
Snr Manager Sterility Assurance Sterility Assurance CSL Seqirus Liverpool, Merseyside, United Kingdom R-288737 Posted on September 25, 2026 employer: CSL Vifor
CSL Vifor in Reading is an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration in the pharmaceutical industry. Employees benefit from comprehensive professional development opportunities and a commitment to compliance and ethical practices, making it a rewarding environment for those passionate about omnichannel marketing. With a focus on employee well-being and a supportive team atmosphere, CSL Vifor stands out as a great place to build a meaningful career.
