Carrie O'keeffe
About Carrie O'keeffe
Carrie O'Keeffe is the Group Quality Director at Dechra Pharmaceuticals PLC, where she has worked since 2021. With extensive experience in quality and regulatory affairs, she has successfully led projects and teams in the pharmaceutical industry across various organizations.
Work at Dechra Pharmaceuticals
Carrie O'Keeffe has served as the Group Quality Director at Dechra Pharmaceuticals PLC since 2021. In this role, she has been instrumental in overseeing quality assurance and regulatory compliance within the organization. Notably, she delivered a 2500 square meter pharmaceutical aseptic manufacturing clean room facility in just eight months, demonstrating her capability in managing complex projects efficiently.
Previous Experience at Wockhardt UK
Before joining Dechra Pharmaceuticals, Carrie O'Keeffe worked at Wockhardt UK as the Director of Quality from 2019 to 2021. In this position, she was responsible for ensuring the quality standards of pharmaceutical products and played a key role in maintaining compliance with regulatory requirements during her tenure.
Education and Expertise
Carrie O'Keeffe earned her Bachelor's degree in Chemistry from Assumption University, where she studied from 1986 to 1990. She possesses strong operational excellence experience, supported by her Lean Six Sigma Green Belt certification. Her educational background and certifications contribute to her expertise in quality management and regulatory affairs.
Career Background in Quality Assurance
Carrie O'Keeffe has extensive experience in quality assurance across various organizations. She has held significant roles at Ipsen, including Head of Quality and Associate Director of Regulatory Affairs, CMC. Additionally, she served as Head of Secondary Projects at Seqirus. Throughout her career, she has established metric and performance-driven organizations and has successfully turned around underperforming teams.
Regulatory Affairs and Achievements
Carrie O'Keeffe has developed strong relationships with regulators in both the US and EU, particularly in the areas of CMC regulatory affairs and quality. She has served as the lead author and program director for biotech BLA and MAA submissions, showcasing her expertise in navigating complex regulatory landscapes and ensuring compliance with industry standards.