Snr 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:

Bachelors 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.

CSL Seqirus is part ofCSL. As one of the largest influenza vaccine providers in the world CSL Seqirusis 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.

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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.

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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 our On the Front Line video to learn more about CSL Seqirus