Meredith Tremblay Email and Phone Number
Meredith Tremblay's Location
Boston, Massachusetts, United States, United States
Meredith Tremblay's Contact Details
Meredith Tremblay work email
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Meredith Tremblay personal email
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Meredith Tremblay phone numbers
About Meredith Tremblay
Meredith Tremblay is a Senior Director, GCP Quality Management at Morphic Therapeutic. She possess expertise in fda, pharmaceutical industry, clinical trials, quality assurance, capa and 12 more skills.
Meredith Tremblay's Current Company Details
Meredith Tremblay Work Experience Details
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Senior Director, Gcp Quality ManagementMorphic Therapeutic Jul 2023 - PresentWaltham, Ma, Us
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Director, Head Of Study Quality And Country Quality, Clinical Development And Operations QualityAlexion Pharmaceuticals, Inc. May 2022 - Jul 2023Boston, Massachusetts, Us•Provide quality leadership to drive clinical quality assurance globally across 20+ developmental programs, 80+ clinical trials (phase 1 through post marketing) and over multiple successful market applications• Extensive experience in leading and supporting various health agency inspections (e.g., FDA, MHRA, PMDA, Swiss medic, Health Canada, EMA, and other health agencies), all with zero critical findings, leading to multiple successful product approvals • Instrumental in leading a cross-functional R&D Risk management and Inspection Readiness Program • Able to effortlessly transition between strategic and tactical roles in an organization that is agile and continuously evolving• Provide strategic direction to drive risk-based quality execution (critical-to-quality risks and mitigation strategies) of the Rare Disease Business Unit portfolio across all therapeutic areas for all studies•Partner with cross-functional teams, other quality groups, and business process owners to drive the effectiveness of business-critical processes/platforms such as TMF, CRO/vendor oversight etc.• Collaborate with cross-functional stakeholders to support audits, inspection readiness, preparation and management, Quality Event management and CAPA Plan development, and execution to closure• Multiple Quality Alexion awards for efficiency in driving quality culture and TA clinical trial compliance -
Director, Head Of Neurology Ta, Clinical Development Quality Operations, R&D QualityAlexion Pharmaceuticals, Inc. Oct 2020 - May 2022Boston, Massachusetts, Us• Lead a team of R&D Quality Operations Leads assuring Neurology portfolio clinical quality oversight and management across the Neurology therapeutic area• Optimize enterprise-level inspection readiness/preparedness framework and resources including but not limited to customized playbook and checklists. leading inspection readiness for assigned programs/portfolio including but not limited to• Provide leadership and guidance to assigned R&D Quality Operations Leads in promoting a culture of inspection readiness and sustainable clinical compliance• Serve as the Subject Matter Expert (SME) and provide guidance on major processes/platform optimization and quality governance requirements including clinical site compliance, investigational product quality matters, and inspection readiness• Serve in an advisory/ consultative role in development of audit strategy for clinical programs, process, and vendor audits• Lead and support risk-based quality management (RBQM) for the planning and execution of clinical protocols
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Senior Director, Clinical Quality Assurance And Compliance (Gcp/Glp/Gvp)Apellis Pharmaceuticals Jan 2020 - Oct 2020Waltham, Ma, Us -
Head Of Gi/Neuroscience Clinical Quality Assurance, R&D QualityTakeda Pharmaceuticals America, Inc. Jun 2019 - Jan 2020 -
Associate Director, R&D Quality Assurance And ComplianceShire Apr 2016 - Jan 2020Tokyo, Jp, Jp•Provide professional expertise and strong leadership in Good Clinical Practice (GCP) and applicable regulations and guidelines•Proactively identify and escalate when necessary compliance risks•Contribute to the development of the Master Audit Plan and execution of audits for assigned Clinical Programs•Co-chair the Joint Quality Council governance team overseeing the preferred partnership with a CRO. Work to optimize quality through a well-executed quality agreement, measurement of KPIs, and clearly-defined communication and escalation pathways.•Lead a team within Quality Assurance to develop a robust and comprehensive inspection readiness program for Phase I-IV Clinical programs. Collaborate with cross-functional stakeholders to effectively implement the process.•Contribute as an SME to various cross-functional initiatives to implement process improvements and/or design new processes aimed at bridging gaps. -
R&D Quality Assurance & Compliance Manager, Clinical And Medical ProgramsShire Mar 2014 - Apr 2016Tokyo, Jp, Jp•Lead a team of auditors in the execution of auditing activities associated with GCPs and applicable regulatory requirements. This includes audits of investigative sites, clinical CROs, IRBs, and vendors.•Serve in an advisory/consultative role in compliance related manners and support project team in implementing corrective and preventative actions•Collaborate with Operations functions to perform program specific root cause analysis of compliance issues, and to provide appropriate metrics for tracking and trending for the overall reporting requirements to functional and senior management•Develop and manage strategies for the preparation, hosting, and responses to regulatory agency inspections for GCP/Sponsor Monitor inspections, inspections and investigator site audit inspections •Assist in the review and identification of potential systemic gaps, and coordinate with appropriate stakeholders to ensure timely remediation
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Senior R&D Quality Assurance & Compliance Specialist, Clinical And Medical ProgramsShire Nov 2011 - Mar 2014Tokyo, Jp, Jp•Manage the internal audit program and assist in the management of the external audit program. Management activities include annual audit planning, resourcing,, and oversight of audit execution from coordination to closure•Select and manage consultants to assist in the conduct of internal and external audits, as well as consultants providing regular on-site and/or ad hoc team support•Audit lead conducting internal GCP system audits, as well as GCP audits of vendors/CROs and investigator sites. This includes effectively liaising with business partners to resolve identified risks•Standing team member on various early and late-phase Clinical Trial Teams (CTTs) providing quality and compliance support to R&D operational staff•Quality and compliance task force lead on corporate implementation teams, including those for the interpretation and integration of updated global regulations (including updated EU Global Pharmacovigilance regulations), as well as vendor management and resourcing strategies•Project lead for tasks such as the development and implementation of an R&D CAPA system, R&D contributions to the Pharmacovigilance System Master File (PSMF), and the collaboration of a multi-disciplinary process for the creation of the Benefit Evaluation as part of the Periodic Benefit-Risk Evaluation Report (PBRER)•Manage responsible R&D functions to ensure the timely closure of CAPAs resulting from internal/external audits, as well as international regulatory inspections•Exemplify strong leadership and provide management to internship roles. This includes assignment of projects as well as guidance on completing tasks•Quality and compliance SME assisting in all inspection-readiness activities and actions, including project lead on the development of inspection readiness tools, as well as hosting of regulatory authorities, and leadership of teams initiated to prepare for specific inspections•Develop and revise quality system documents, as needed
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Audit And Compliance Expert, Global Pharmacovigilance And Risk ManagementSanofi Genzyme Nov 2005 - Nov 2011Paris, France, Fr
Meredith Tremblay Skills
Fda
Pharmaceutical Industry
Clinical Trials
Quality Assurance
Capa
21 Cfr Part 11
Biotechnology
Validation
Sop
Clinical Development
Regulatory Submissions
Oncology
Gmp
Regulatory Affairs
Biopharmaceuticals
Glp
Drug Development
Meredith Tremblay Education Details
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Northeastern UniversityRegulatory Affairs -
Umass Boston2012 Emerging Leader Program
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Northeastern UniversityBehavioral Neuroscience
Frequently Asked Questions about Meredith Tremblay
What company does Meredith Tremblay work for?
Meredith Tremblay works for Morphic Therapeutic
What is Meredith Tremblay's role at the current company?
Meredith Tremblay's current role is Senior Director, GCP Quality Management.
What is Meredith Tremblay's email address?
Meredith Tremblay's email address is mt****@****eda.com
What is Meredith Tremblay's direct phone number?
Meredith Tremblay's direct phone number is +178148*****
What schools did Meredith Tremblay attend?
Meredith Tremblay attended Northeastern University, Umass Boston, Northeastern University.
What skills is Meredith Tremblay known for?
Meredith Tremblay has skills like Fda, Pharmaceutical Industry, Clinical Trials, Quality Assurance, Capa, 21 Cfr Part 11, Biotechnology, Validation, Sop, Clinical Development, Regulatory Submissions, Oncology.
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