Head of Site Compliance
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Overview
Job Description
Responsibilities:The role holder is responsible for completing the site master file and self-inspection program, ensuring site compliance with GMP/GxP standards and regulatory requirements, and managing local quality reviews, KPIs, and contributing to global quality reviews. They provide impartial quality oversight and work closely with the FLQA organization.
Additionally, they organize and facilitate external regulatory, CSL corporate, and customer audits, oversee preparation and readiness for regulatory inspections and third-party audits, and manage inspection results, corrective actions, and timely responses to authorities. They also perform gap assessments, evaluate site compliance with audit outputs and regulatory changes, coordinate site-based gap assessments, and liaise with global Compliance and Risk groups.
The role holder is responsible for facilitation of the site Change control review panel and the site Deviation Review Board meetings, as assigned.
The role holder is responsible for preparation, facilitation and governance of the site Quality Plan.
Qualifications:• Degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry); advanced degree preferred• 7+ years' experience in quality/GMP in the pharmaceutical/biotech industry including 1-3 years' leadership/team management experience• Experience within a global matrix organization• Demonstrated success in project management and business/QA systems• Knowledge of appropriate regulatory requirements including GMP/GQPDifferent 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
Automate your job search with Sonara.
Submit 10x as many applications with less effort than one manual application.
