Global VP of Quality - Biologics

Catalent•Bridgewater, NJ

26d

About The Position

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 Role 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 execution and outcomes on critical deviations provide clear direction and oversight including the review and approval of the deviations as well as effective CAPA plans Deliver on the annual goals and objectives established with and approved through the business unit. Demonstrate strong business and fiduciary responsibility in the management of their budgets, and broader business decision-making, acting as both functional and business leaders. Development of strong customer relationships, partnering with other Catalent leaders to establish outstanding performance and customer impact that acts as a true competitive differentiator. Evaluate existing processes and identifies improvement to enhance efficiency, consistency, and competitiveness within the market. Stay current on industry trends and integrate, as appropriate new technologies. Represent Catalent and industry consortiums.

Requirements

Bachelor's or Master's Degree in science, pharmacy or related discipline is required.
Extensive experience (10+ yrs) in biologics ATMP (Advanced Therapeutic Medicinal Products) is a requirement.
Experience in managing a multi-site quality function in Biologics, ATMP’s or Vaccines is required.
Indirect responsibility for the quality function of over 200 people.
Demonstrated business acumen and ability to manage through difficult discussions with clients.
Experience in managing a multi-site quality function in Biologics or Vaccines is required.
Ability to operate effectively in an environment with high levels of ambiguity.
Proven critical thinking aptitude in a demanding and fast paced environment
Possesses visionary leadership; ability to identify new trends in the quality and regulatory landscape, allowing Catalent to lead the industry.
Proven experience in driving substantial improvements of quality performance across a broad range of initiatives including development and recruitment of talent, process improvements, elimination of exceptions/SOP standardization.
Demonstrated experience of successfully leading a multi-site Quality leadership team, preferable in a matrix-style organization.
Knowledge of global cGMP regulations including FDA, EMA, ANVISA, and other Tier 1 regulatory agencies.
Demonstrated success in executing multiple major quality initiatives (such as: implementation of IT systems, upgrading plant regulatory status, commissioning new plant operation, etc.).
Must possess significant learning agility and must be able to get to the heart of issues succinctly and propose ideas with conviction.
Continuous improvement mind-set and disposition is critical.
Provides reliable / defendable interpretations of regulatory guidance for the customer and is capable of defending these positions to regulatory agencies.
Ability to effectively present information and respond to questions from Executive Leadership team.

Nice To Haves

MBA or PhD as educational background is an advantage

Responsibilities

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 execution and outcomes on critical deviations provide clear direction and oversight including the review and approval of the deviations as well as effective CAPA plans
Deliver on the annual goals and objectives established with and approved through the business unit.
Demonstrate strong business and fiduciary responsibility in the management of their budgets, and broader business decision-making, acting as both functional and business leaders.
Development of strong customer relationships, partnering with other Catalent leaders to establish outstanding performance and customer impact that acts as a true competitive differentiator.
Evaluate existing processes and identifies improvement to enhance efficiency, consistency, and competitiveness within the market.
Stay current on industry trends and integrate, as appropriate new technologies.
Represent Catalent and industry consortiums.

Benefits

Join a high growth and fast paced organization with a people focused culture
Global exposure, defined career path and annual performance review and feedback process
Competitive Medical, Dental, Vision and 401K
26 days PTO & 8 paid holidays
Catalent offers rewarding opportunities to further your career!
Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world.
Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.
Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us.
Join us in making a difference.
personal initiative.
dynamic pace.
meaningful work.