Head of Site Compliance

Seqirus • Holly Springs, NC

3d

About The Position

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/ .

Requirements

• Degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)
• 7+ years' experience in quality/GMP in the pharmaceutical/biotech industry
• 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/GQP

Nice To Haves

• advanced degree preferred

Responsibilities

• Completing the site master file and self-inspection program
• Ensuring site compliance with GMP/GxP standards and regulatory requirements
• Managing local quality reviews, KPIs, and contributing to global quality reviews
• Providing impartial quality oversight and working closely with the FLQA organization
• Organizing and facilitating external regulatory, CSL corporate, and customer audits
• Overseeing preparation and readiness for regulatory inspections and third-party audits
• Managing inspection results, corrective actions, and timely responses to authorities
• Performing gap assessments, evaluating site compliance with audit outputs and regulatory changes
• Coordinating site-based gap assessments and liaising with global Compliance and Risk groups
• Facilitation of the site Change control review panel and the site Deviation Review Board meetings, as assigned
• Preparation, facilitation and governance of the site Quality Plan

Benefits

• For more information on CSL benefits visit How CSL Supports Your Well-being | CSL .

What This Job Offers

• Job Type: Full-time
• Career Level: Senior