Global VP of Quality - Biologics

Global VP of Quality - Biologics

Position Summary:

Reporting to the Senior Vice President of Quality & Regulatory Affairs and working closely with SVP Operations and the Divisional President, the Global Vice President of Biologics and leads global strategy and operations for biologics and Advanced Therapeutic Medicinal Products (ATMP). This executive oversees R&D, manufacturing, regulatory compliance, and commercialization, ensuring scientific quality and operational efficiency.

The role is responsible for implementing quality and regulatory strategies, maintaining effective staffing and talent development, and supporting strategic growth plans across multiple sites (5,) in multiple regions with staffing levels above 500 people. As a member of the Biologics leadership team, the VP of Quality promotes a Patient First culture, manages Site Quality Directors, enforces consistent quality standards, and addresses performance issues collaboratively with customers.

Serving on the Catalent Senior Leadership Team, this leader is expected to provide impactful guidance organization-wide.

Additionally, the VP manages budgeting and sourcing for the Quality Unit, ensuring timely product release and cost controls. The incumbent is responsible support customer interface and exchanges during all aspects of the product lifecycle from pre supply through commercial manufacturing. The position provides critical direction and where appropriate decisions supporting product quality.

The Quality Unit provides directions to ensure compliance with all global regulatory requirements for the markets they serve and ultimately has the responsibility to approve or reject incoming materials, in-process, components, and finished products. The main responsibilities for the Quality Unit are:

• Establishing and maintaining governance over the Quality Management System to ensure the site is operating effectively and in a state of control and build a culture of quality
• Provide strategic direction, quality plans and staffing requirements in line with SLT to drive business priorities
• Ensuring that controls are implemented and completed satisfactorily during manufacturing operations.
• Ensuring that developed procedures and specifications are appropriate and followed.
• Approving and rejecting incoming materials, in-process materials and drug products.
• Reviewing production records and investigating any unexplained discrepancies.
• Ensuring Executive management is well informed, advised and where appropriate makes decisions that are under the responsibility of the Quality Unit. Provides guidance, actions and risk mitigation plans and advice on strategic initiatives and other relevant ongoing operational issues/performance.
• Partner effectively with other functional leaders (Product Development, Operations, etc.) and Site General Managers to develop and maintain a meaningful and robust Quality and Patient First and Quality culture across all aspects of the business.
• Champion, through clear and visible advocacy, Catalent's Quality Management System (QMS), and ensure strong technical and leadership capability at all levels of the Quality organization.
• Responsibility for ensuring the site Quality leadership teams is staffed with high caliber Quality leaders and professionals, driving strong and effective performance culture at all levels across the sites, and creating a strong succession pipeline for key leadership roles.
• Define activity-based cost models and work with sites to establish and execute a budget that is in-line with the requirements of the business to deliver on the testing, release and QMS commensurate with the needs of the business to operate effectively and efficiently.
• Ensure appropriate metrics and reporting/escalation processes are in place and being utilized to drive and improve required operational execution and performance levels and drive appropriate corrective actions planning when needed.
• Drive actions and remediation as required to meet the quality performance and standards sets for the site.
• Prepare regulatory observation responses and regulatory CAPA plans to meet expectations, ensuring accuracy and completeness.
• Drive…