Laura J. Email & Phone Number
Consultant, Quality Operations, CMC
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Laura J. Location
- McHenry, IL, US
Laura J. Work
- 2025 -now Consultant, Quality Operations, CMC @ Praxis Precision Medicines, Inc.
- 2023 -2025 Consultant, GCP Quality Project Management @
- 2022 -2023 Consultant, Quality Systems Implementation @
- 2021 -2022 Global CAPA Process Lead @
- 2021 -2021 Consultant, QA Change Management @
- 2019 -2020 Director, Quality and Regulatory @
- 2018 -2019 Associate Director, External Audits @
- 2017 -2018 GMP QA Consultant @
- 2016 -2017 Director, Quality Compliance @ Mylan Institutional Inc
- 2014 -2016 Change Management, Special Projects Manager @
- 2012 -2014 Quality Consultant @ IBF Quality Solutions
- 2008 -2012 R and D Quality Manager @
- 2005 -2008 Regulatory Affairs Consultant @ RMTW, Inc
Laura J. Education
- Keller Graduate School of Management of DeVry University
Master of Business Administration - MBA (Business Administration and Management, General)
- University of Cambridge
- Valparaiso University
Bachelor of Science (B.S.) (Chemistry)
Laura J. Skills
- Document Management Systems (DMS)
- Vendor Qualification
- Consulting
- Clinical Trials
- FDA GMP
- Product Quality
- Training Management
- Audit Management
- Good Clinical Practice (GCP)
- Project Management
- Inspection Readiness
- Change Management
- Data Management
- Risk Management
- Regulatory Compliance
- Supplier Quality
- GMP
- FDA
- Quality System
- CAPA
- Validation
- Quality Assurance
- Change Control
- Regulatory Affairs
- Process Improvement
- Quality Control
- Pharmaceutical Industry
- GLP
- Quality Auditing
- ISO 13485
- Quality Management
- Risk Assessment
- GxP
- Regulatory Requirements
- Standard Operating Procedure (SOP)
- Gap Analysis
- Compliance Remediation
- Pharmaceutics
- Regulatory Submissions
- U.S. Food and Drug Administration (FDA)
- Aseptic Processing
- Design Control
- Corrective and Preventive Action (CAPA)
- ISO 14971
- Six Sigma
- Business Process Improvement
- U.S. Title 21 CFR Part 11 Regulation
- Cross-functional Team Leadership
Laura J. Summary
- Laura J., based in McHenry, IL, US, is currently a Consultant, Quality Operations, CMC at Praxis Precision Medicines, Inc.. Laura J. brings experience from previous roles at Vertex Pharmaceuticals, Imago Rehab, Hillrom and Astellas Pharma US. Laura J. holds a Master of Business Administration - MBA in Business Administration and Management, General @ Keller Graduate School of Management of DeVry University. With a robust skill set that includes Document Management Systems (DMS), Vendor Qualification, Consulting, Clinical Trials, FDA GMP and more.
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