Michelle Bourke Email
Quality and Compliance Lead @ Alexion Pharmaceuticals, Inc.
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Michelle Bourke Location
- Ireland
Michelle Bourke Work
- 2024 -now Quality and Compliance Lead @
- 2023 -2024 Associate Director Quality Compliance @
- 2021 -2023 Sr Manager, Quality Compliance @
- 2021 -2021 Principal Quality Assurance Auditor @
- 2015 -2021 Sr Quality Assurance Auditor @
- 2013 -2015 Quality Assurance Auditor II @
- 2011 -2013 Quality Assurance Auditor @
- 2007 -2011 Data Managament Study Lead @
Michelle Bourke Education
- Institute of Technology Tallaght
BSc Pharmaceutical Science (Bio-Pharmaceutical Production)
2003-2007
Michelle Bourke Skills
- 21 CFR Part 11
- Clinical Data Management
- ICH-GCP
- Pharmaceutical Industry
- Data Management
- GCP
- Oracle Clinical
- Clinical Trials
- EDC
- CRO
- CTMS
- Regulatory Submissions
- Sop
- Quality Assurance
- FDA
- CAPA
- Regulatory Requirements
- Inform
- Protocol
- GLP
- Regulatory Affairs
- Pharmacovigilance
- Therapeutic Areas
- Clinical Development
- Validation
- Ich Gcp
Michelle Bourke Summary
- Michelle Bourke, based in Ireland, is currently a Quality and Compliance Lead at Alexion Pharmaceuticals, Inc.. Michelle Bourke brings experience from previous roles at Alexion Pharmaceuticals, Inc. and ICON plc. Michelle Bourke holds a 2003 - 2007 BSc Pharmaceutical Science in Bio-Pharmaceutical Production @ Institute of Technology Tallaght. With a robust skill set that includes 21 CFR Part 11, Clinical Data Management, ICH-GCP, Pharmaceutical Industry, Data Management and more. Michelle Bourke has 2 emails on RocketReach.
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