Nora Carey
Senior Director, Quality Operations at Ipsen
- Role
- Senior Director, Quality Operations, North America at Ipsen
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Nora Carey
Pharmaceutical Quality professional with over 25 years of experience who creates a culture of quality excellence, GxP compliance, and continuous improvement. Collaborative leader and mentor with experience in QMS management, product disposition, commercial product launch, serialization, product complaints, regulatory inspection hosting, metrics reporting, CMO and third-party logistics provider oversight, PV and MI support, quality auditing, shipping validation, cold chain management, aseptic fill-finish, labeling, packaging, and distribution of commercial and late phase clinical drug products.
Experience
Senior Director, Quality Operations, North America
Mar 2023 — Present · US
Education
University of Strathclyde
Master of Science (MSc), Pharmaceutical Quality and Good Manufacturing Practice
2009 — 2013
Eastern Nazarene College
Master of Science (MS), Management
2004 — 2006
Eastern Nazarene College
Bachelor of Science (BS), General Science/Biology
1996 — 2000
Skills
- Gmp
- Capa
- Fda
- Aseptic Processing
- Trackwise
- Validation
- Change Control
- 21 Cfr Part 11
- Gxp
- Sop
- Quality System
- Biotechnology
- Lims
- Regulatory Affairs
- Pharmaceutical Industry
- Biopharmaceuticals
- Quality Auditing
- Regulatory Requirements
- Quality Control
- Deviations
- Chromatography
- Analytical Chemistry
- Sop Development
- Aseptic Technique
- Vaccines
- Contract Manufacturing
- Quality Assurance
- Corrective and Preventive Action (Capa)
- Standard Operating Procedure (Sop)
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