Anne Leonard
Site Head of Quality at MilliporeSigma, a business of Merck KGaA of Darmstadt, Germany
- Role
- Site Head of Quality at MilliporeSigma
- Location
- Bloomington, IN, US
- LinkedIn followers
- 500 followers
About Anne Leonard
Transformational Quality leader with 25 years CDMO sterile fill-finish experience. Successful history leading strategy and improvement initiatives in quality operations, deviation investigation and CAPA system, change control, product release, risk management, and sterility assurance. Proven success leading site remediation and organizational and cultural change.
Experience
Site Head of Quality
Jun 2023 — Present · Indianapolis, IN, US
Head of Quality for CDMO offering lipid nanoparticle (LNP) and other complex drug substance formulation, aseptic drug product filling site, analytical method development and stability programs• Led successful transformation of Quality organization and site quality culture post acquisition through a program of risk assessment and mitigation, process improvement and talent development• Collaborated with global customers to develop strategic initiatives for delivering commercial and clinical supply• Facilitated multiple successful inspections by FDA and other regulatory bodies with successful outcomes
Education
Indiana University Bloomington
BS, Biology
1996 — 2000
Indiana Wesleyan University
MBA
2003 — 2005
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