Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here
Reporting directly to the Vice President of Quality, Biologics and with strong working relationship with the Site General Manager as well as SVP Quality, this key leadership position is accountable for ensuring the successful delivery of quality and regulatory strategy and operational performance at the Bloomington, IN facilities.
The focus will be on building talent bench strength at the site level, building quality capacity to meet expected demand increases, integrate into and leverage the entire Catalent network, execute on growth strategies, lead quality-related aspects of the transition into commercial manufacturing, and deliver on regulatory approval of the manufacturing site.
Partner effectively with other functional leaders (Manufacturing, Operations, etc.) and Site General Manager to develop and maintain a meaningful and robust 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.
Work with Site Quality Directors and General Manager to translate and operationalize Quality, Regulatory and Compliance strategy in a way that is appropriate for individual sites while maintaining a robust "One Catalent" QMS.
Responsibility for ensuring the site Quality leadership teams are 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.
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.
Bachelor's or Master's Degree in science, pharmacy or related discipline is required. MBA or PhD as educational background is a plus.
Experience in managing a site quality function in Biologics or Vaccines is required.
Ability to be on-site at the Bloomington, IN location is required (relocation support available).
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.
Knowledge of global cGMP regulations including FDA, EMA, ANVISA, and other Tier 1 regulatory agencies with a continuous improvement mind-set and disposition is critical.
Leads through influence and able to leverage the matrix.
Provides reliable / defendable interpretations of regulatory guidance for the customer and is capable of defending these positions to regulatory agencies.
Internal Number: 0047082
About Catalent Pharma Solutions
Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs approximately 14,000 people, including around 2,400 scientists and technicians, at more than 45 facilities, and in fiscal year 2020 generated over $3 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey.