Jennifer Leale
Director, Quality Assurance & Regulatory Affairs @Grand River Aseptic Manufacturing
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WORK HISTORY
Director, Quality Assurance & Regulatory Affairs @Grand River Aseptic Manufacturing
Grand Rapids, MI, US
Provide direction and oversight to Grand River Aseptic Manufacturing (GRAM) quality systems, the Quality Assurance and Regulatory Affairs functions, as well as the Non-Conformance, CAPA and Change Management processes for GRAMs clinical and commercial operations.
EDUCATION
Hope College
Bachelor of Science (B.S.), Chemistry
SKILLS
ABOUT JENNIFER LEALE
During my career, I have had a variety of responsibilities within Quality supporting API and DP manufacturing. Responsibilities have included Site Compliance functions, Product Change Requests, Annual Product Reviews, deviation resolution and assisting in defining process improvement opportunities. Primary interface with Third Party suppliers and provided QA support for various product introduction projects. I have also been a QA Manager for various teams, including an Early Stage Testing Laboratory, Method Validation and Cleaning Validation, Non-Sterile Liquids & Semi-Solids, Biological Processing, Sterile Manufacturing and Medical Devices quality teams. I supported the Pfizer CentreOne (PC1) business as a Business Operations Lead responsible for the development and implementation of short and long-term PC1 business process/portfolio/resource strategy. I was also a Development Services Manager, responsible for leading the on-boarding of the Pfizer Kalamazoo site in the PC1 drug product (DP) contract manufacturing (CM) network, facilitating site evaluations of CM opportunities and program management of the portfolio. Currently, I am the Director of Quality at Grand River Aseptic Manufacturing, providing leadership to Quality Assurance, Quality Control, and Compliance functions. This includes ensuring adequate quality oversight of all GRAM clinical and commercial operations.
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