Manish R Email & Phone Number
Clinical and PV QA and Compliance Management Leader @ Pacira BioSciences, Inc.
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Manish R Location
- Boston, MA, US
Manish R Work
- 2025 -now Clinical and PV QA and Compliance Management Leader @
- 2024 -2025 Quality Assurance Management Professional @
- 2021 -2024 Director Of Clinical Quality Assurance @
- 2020 -2021 Director of Clinical Development Quality Assurance @
- 2018 -2020 Associate Director Clinical Quality @
- 2017 -2018 Associate Director of Global Regulatory Affairs (Operations and Quality Management) @
- 2014 -2017 Associate Director of GCP Quality Assurance (Operations and Audit Management) @
- 2011 -2014 Director of Quality Assurance @ Cambridge Biomedical Inc.
- 2011 -2012 President and Vice President @
- 2004 -2011 Quality Assurance Manager GXP (GCP and GLP and GMP) and IT @
- 2008 -2009 Secretary @ New England Regional Chapter Society of Quality Assurance
- 2000 -2004 Sr. Systems Analyst and Computer System Validation Analyst (Clinical and Laboratory) @
- 1999 -2000 Information Systems and Computer Validation Consultant (GXP) (KMI and Parexel) @
- 1997 -1999 Quality Assurance and Quality Control Analyst (GMP and GTP) @ Diacrin Inc.
- 1996 -1997 Quality Control Microbiologist (GMP) @ Genetics Institute
Manish R Education
- RAPs
Regulatory Affairs Certificate (Medical Devices and Pharmaceuticals)
2014-2015 - RPI Lally School of Management
MS (Management (Technology))
2004-2006 - University of Massachusetts Amherst
B.S. (Medical Technology)
1994-1995 - University of Massachusetts Amherst 1990-1994
Manish R Skills
- GMP QC Labs, Sterile MFG. Facilities
- QAV for Validation Support
- Laboratory Audits
- CSV/IT Audits
- Clinical Site Audits
- Laboratoy Audits
- Data Integrity Audits
- Supplier Audits
- IT Audit
- CSV Audit
- GAMP
- Regulatory Affairs
- Regulatory Operations
- Inspection Support
- Risk Management
- Vendor Audit
- Clinical Site Audit
- BIMO Inspection Readiness
- Operational Strategy
- Operations Management
- Executive Management
- Non-profit Management
- Team Leadership
- Business Development
- Method Validation
- LDTs
- IVDs
- GCLP
- CAP
- Clia
- Clinical Practices
- Release Management
- Defining Requirements
- Computerized Systems
- CSA 2010
- CAPAs
- Preventive Actions
- Data Integrity
- Research and Development (R&D)
- GCP
- GLPs
- GLP
- GMP
- Clinical Trials
- Validation
- 21 CFR Part 11
- Computer System Validation
- FDA
- Biotechnology
- GxP
- CAPA
- Quality Assurance
- Pharmaceutical Industry
- Quality System
- CRO
- Quality Control
- CSV
- U.S. Food and Drug Administration (FDA)
- Good Laboratory Practice (GLP)
Manish R Summary
- Manish R, based in Boston, MA, US, is currently a Clinical and PV QA and Compliance Management Leader at Pacira BioSciences, Inc.. Manish R brings experience from previous roles at Zigzag Associates Ltd, Dyne Therapeutics, Voyager Therapeutics, Inc. and Alexion Pharmaceuticals, Inc.. Manish R holds a 2014 - 2015 Regulatory Affairs Certificate in Medical Devices and Pharmaceuticals @ RAPs. With a robust skill set that includes GMP QC Labs, Sterile MFG. Facilities, QAV for Validation Support, Laboratory Audits, CSV/IT Audits, Clinical Site Audits and more. Manish R has 2 mobile phone numbers on RocketReach.
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Top Pacira BioSciences, Inc. Employees
Chris Young
Chief Manufacturing Officer
New York, NY, US
John Bartolick
Vice President Information Technology
New York, NY, US
Susan Mesco
Vice President Investor Relations
Parsippany-Troy Hills, NJ, US
James Paiva
Vice President and General Manager
Warren, RI, US
Suzanne Monahan
Senior Vice President, Head of Sales
New York, NY, US
Dan Copeland
Vice President and General Manager
San Diego, CA, US
Anthony Molloy
Chief Legal Officer and Chief Compliance Officer
Bernards, NJ, US
Dennis McLoughlin
Chief Commercial Officer
Bradenton, FL, US
Scott Ring
Vice President Information Technology
Metuchen, NJ, US
Kristen Williams
Chief Administrative Officer, Corporate Secretary
Parsippany-Troy Hills, NJ, US
Jonathan Slonin
Chief Medical Officer
Palm City, FL, US
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