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.
About CSL Seqirus
CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
Watch our ‘On the Front Line’ video to learn more about CSL Seqirus
Snr Manager Sterility Assurance in Liverpool employer: Seqirus Vaccines Limited
CSL Seqirus is an exceptional employer, offering a dynamic work environment where innovation and inclusion are at the forefront. With a commitment to employee growth and development, team leaders have access to comprehensive benefits and opportunities to lead impactful projects in a state-of-the-art facility dedicated to global health. Located in a vibrant community, CSL Seqirus fosters a culture of curiosity and empathy, making it a rewarding place for those looking to make a difference in the world of healthcare.
