Head of Site Quality

The Senior Director, Site Quality Head will provide strong leadership and strategic direction to the site quality organization as well as building and maintaining a quality culture at CSL Behring. You will manage, direct, and maintain the company’s quality assurance activity to ensure regulatory compliance of all internal GMP functions. This individual has the ultimate accountability for Quality at the site and will be the main Quality contact, and license holder where applicable, for external regulatory agencies during inspections and inquiries. Senior Director, Site Quality Head will ensure the appropriate implementation and execution of the CSL enterprise-wide Quality Management System that contains standardized Quality processes, practices, technology, and standards for CSL. You will have demonstrated strong technical knowledge and cGMP compliance. You must have demonstrated capabilities in execution of risk-based and compliant quality assurance, compliance programs and systems in support of the company infrastructure to fully support CSL Behring manufacturing activities. You must have the ability to lead a site-based Operational Quality team. You will be a member of the Global Quality Leadership Team and the Site Leadership Team. As part of a global organization, you will require up to 10% travel for leadership meetings. The position requires the ability to build and maintain strong relationships and collaborate effectively with all levels and cross functionally within the organization.

You will report to VP, Head of Global Quality, CSL Behring and be located in the CSL Behring Kankakee manufacturing facility.

Directing reporting into:

• Quality Value Stream Leads

• Batch Release

• Quality Compliance Lead

• Administrative Assistant

• Collaborate with internal partners to enable compliant and successful manufacturing (e.g., technology transfers, validation, testing, release, and lifecycle management)

• Provide 24/7 Quality Assurance support to the Value Streams on the manufacturing site.

• Partner with all departments to identify and mitigate Quality issues/concerns.

• Ensure implementation and adherence to the CSL QMS, including diligent deviation management and change control management.

• Ensure that the pharmaceutical intermediates and/or products released at are manufactured and tested in accordance with GMP and any relevant regulations, applicable specifications, and regulatory filings.

• Collaborate with Global Safety and Pharmacovigilance, to monitor and control drug safety in relation to the quality of the products manufactured at the site.

• Oversee site self-inspection processes and execution.

• Ensure preparation, successful conduct and follow-up of all regulatory inspections and customer audits.

• Lead the Site Quality Leadership team to develop cross functional ways of working, foster collaboration and develop the Site-based Quality community.

• Ensure that the cross functional Quality governance and project forums are sponsored and supported appropriately, delivering outputs as required.

• Be the primary contact for Quality as it relates to regulatory inquiries or inspections.

• Collaborate with Global Quality Systems and Compliance to implement enterprise wide QMS and compliance processes.

• Degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry) or comparable education; advanced master’s degree preferred.

• 12 years' experience in Quality/GMP in the pharmaceutical industry including team management and Leadership experience.

• Experience in Operations and Quality Control would be preferable.

• Advanced knowledge of pharmaceutical regulatory requirements including GMP.

• Demonstrated Experience with US FDA and international inspections.

• Expertise in project management and business/Quality systems.

• Demonstrate organizational and interpersonal skills at the executive level.

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our benefits site to see what’s available to you as a CSL employee.

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

As a global organization with employees in 35 countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

About the Company:
CSL Behring