Melanie Pomerleau
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Vice President Quality and Compliance
Montreal, Quebec, Canada
Résumé
Jobs
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Vice President Quality and ComplianceIndero formerly InnovadermFeb 2024 - Current (2 years 9 months)- Sr. Director Quality and Compliance|Quality OfficerIndero formerly InnovadermJun 2019 - Feb 2024 (4 years 9 months)-Promotes quality culture within the company;
-Develops and ensures the implementation of the annual objectives of the department;
-Ensures that the deliverable and activities meet the expectations of internal clients;
-Manages Innovaderm's quality systems (SOP, LMS, training, non-compliances/ CAPA);
-Develops the annual audit program
-Organize and host client audits and regulatory inspections;
-Ensure on-time implementation of corrective and preventive actions within the company
-Acts as a consultant on regulatory issues and good practices;
-In charge of quality indicators (KPIs) - IDirector of Quality AssuranceInnovaderm Research IncFeb 2018 - Jun 2019 (1 year 5 months)-Responsible for the performance and achievement of the objectives set for the QA team.
-Ensures that all clinical research activities are conducted in accordance with Good Clinical Practice, regulatory requirements and the implementation of standard operating procedures.
-Planning, organization, monitoring, performance and management of quality assurance activities. - Head of Clinical QualityEndoceuticsSep 2012 - Feb 2018 (5 years 6 months)-Drive quality management and risk assessment initiatives
-Develop audit plan for phase I to III studies and perform audit of clinical sites in U.S. and Canada
-Manage quality systems, KPIs, internal audits and vendor program
-Computer system validation evaluation
-Facilitate third-party audits including health authorities inspections
-Provide consultation, training, and other supportive services necessary to maintain compliance - Senior CRA (Contract)PharmascienceMar 2011 - Sep 2012 (1 year 7 months)-Act as central CRA for clinical studies performed in Canada and India
-Review protocols, ICFs and Clinical Study Reports
-Ensure project management for achievement of clinical timelines - MRegional Manager Quality AssuranceMDS Pharma Services now CelerionJan 2008 - Mar 2010 (2 years 3 months)-Oversight of quality for 2 sites in North America
-Management role for 12 Quality Assurance Auditors
-Implementation of Quality Systems and annual program (internal/external audits)
-Management of CAPA and Investigations as well as ethical issues
-Client and Regulatory audits - Coordinator Quality Assurance (Manager Level)AnapharmSep 2004 - Dec 2007 (3 years 4 months)-Oversight of Quality for 2 sites in Canada (Montreal and Toronto)
-Act as Manager for the Quality Assurance team (12 auditors)
-Implement Quality Systems
-Ensure that clinical trial are performed as per applicable regulations
-In charge of regulatory audits preparation and client visits - Senior Auditor, Quality AssuranceAnapharmNov 2001 - Sep 2004 (2 years 11 months)
- AnalystScheringPloughDec 1999 - Nov 2001 (2 years)
- Project Manager-Pharma ServicesMaxxam AnalyticsJan 1999 - Dec 1999 (1 year)
- MTeam Leader-HPLCMDS NeopharmMay 1997 - Dec 1999 (2 years 8 months)
Education
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- Attestation, Drug DevelopmentUniversité LavalJan 2003 - Jan 2004 (1 year 1 month)
- LDEC, Chemistry-BiologyLévisLauzon CollegeJan 1994 - Jan 1997 (3 years 1 month)
- Certificate, CommunicationUniversité de MontréalOngoing