Jennifer Gavin Email and Phone Number
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Exceptional leadership and interpersonal skills driving collaboration to ensure successful quality outcomes. Diverse regulatory and quality experience across GCP and GMP environments, including top-tier pharmaceutical companies; CROs; and excipient manufacturing. Extensive quality experience with progression in roles of increasing responsibility.Areas of expertise include: inspection management; global regulatory compliance; quality issue management; CAPA management; quality management systems and standards; client relations; and metrics reporting and trend analysis.
Novartis
View- Website:
- novartis.com
- Employees:
- 79781
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Head Inspection Strategic Operations, Global Development QualityNovartisPhiladelphia, Pa, Us
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Senior Country Clinical Quality Management Lead (Director Of Clinical Research)Merck Sep 2024 - Present
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Head Inspection Strategic Operations, Global Development QualityNovartis Jul 2022 - Sep 2024Basel, Baselstadt, ChLead and manage the Inspection Compliance Committee, a global cross functional committee created to support inspection process execution and ensure on-time and effective GCP CAPA creation and resolution for Health Authority commitments.Ensure implementation and evolution of global GCP Inspection Management processes, SOPs, trainings, and lessons learned in alignement with Health Authority regulations and guidelines.
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Inspection Strategic Operations Lead, Global Drug Development- Regulatory AffairsNovartis Sep 2020 - Jun 2022Basel, Baselstadt, ChDeveloped and maintained GCP Inspection Management processes, SOPs, trainings, to ensure optimal pre-approval and supervisory GCP Health Authority Inspection outcomes are obtained.
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Associate Director, Global Development Quality AssuranceNovartis Oct 2016 - Aug 2020Basel, Baselstadt, ChProvided strategic and proactive Quality Assurance guidance and consultation for assigned Global Clinical Teams within Development Franchises. Oversaw quality risk management processes including quality risk assessments and submission/inspection readiness activities to ensure clinical trial processes were in control.
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Interim Head, Client Engagement, Quality Assurance And ComplianceCovance Apr 2016 - Oct 2016Princeton, New Jersey, UsA member of the RCQA Leadership Team and Client Engagement Functional Head.Ensured quality assurance oversight and risk mitigation across all client portfolios; including: QA-QA interactions with clients in support of quality plans/agreements; oversight of SOPs/processes; issue management; and assessment of quality metrics for mitigation of quality issues.Represented QA during bid-defenses, engaged with clients to strategize and develop quality assurance oversight. -
Senior Manager, Client Engagement, Quality Assurance And ComplianceCovance Sep 2015 - Apr 2016Princeton, New Jersey, UsManaged and oversaw QA Lead staff.Ensured QA-QA client interactions and deliverables in support of client-quality governance..Represented Client Engagement in support of client audits and inspection management.
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Manager, Quality Assurance And ComplianceCovance Mar 2014 - Sep 2015Princeton, New Jersey, UsProvided QA oversight and quality risk analysis for all projects phases II-IV within assigned client portfolios.
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Senior AuditorCovance Aug 2012 - Mar 2014Princeton, New Jersey, UsAssured all systems and processes complied with internal and client standards and met applicable regulations and guidelines, through the conduct and completion of audits (investigator site, vendor, Trial Master File, and process). Mentored and trained new staff and provided QA oversight for all Phase IV studies.
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Auditor ICovance Apr 2011 - Aug 2012Princeton, New Jersey, UsConducted investigator site, vendor, Trial Master File, and process audits, and ensured appropriate remediations via the CAPA process.
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Regulatory Affairs AssociateCovance May 2009 - Apr 2011Princeton, New Jersey, UsReviewed and green lighted all pertinent regulatory documents required for site initiation. Managed the SOP process to ensure compliance with organizational and Health Authority requirements. Facilitated all internal sponsor audits and acted as intermediary for the CAPA process.
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Clinical Research AssociateCovance Sep 2008 - May 2009Princeton, New Jersey, UsActed as the liaison between the study team and the investigators, conducting study visits in a timely manner and ensuring compliance with regulatory requirements and the clinical trial protocol.
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Regulatory Assessment CoordinatorColorcon Jan 2008 - Sep 2008Harleysville, Pa, UsResearched and evaluated all raw materials for regulatory compliance to ensure viability of the finished product in the projected markets. -
Senior Regulatory Affairs AssociateColorcon Jan 2005 - Jan 2008Harleysville, Pa, UsAssured the integrity and the expedited flow of all government required documents pertaining to current and evolving global excipient regulations. Co-managed the implementation of the company’s material safety data sheet system and global color regulation database.
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Regulatory Affairs AssociateColorcon Jul 2004 - Jan 2005Harleysville, Pa, UsPrepared regulatory submissions and insured accuracy of customer requests as sales intermediary.
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Post Audit Denial CoordinatorAhp Settlement Trust Jan 2004 - Jul 2004UsManaged a post audit group toward final settlement of all high dollar claims. -
Surgery Project SpecialistAhp Settlement Trust Sep 2003 - Jan 2004UsAssessed patient medical records against cardiology claims and court mandates, to determine claim relevancy and payout.
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Quality AssuranceAhp Settlement Trust Jul 2003 - Sep 2003UsPromoted to QA. Charged with the final satisfactory verification of claims prior to audit.
Jennifer Gavin Skills
Jennifer Gavin Education Details
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Temple UniversityQuality Assurance And Regulatory Affairs -
Temple UniversityQuality Assurance And Regulatory Affairs
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Saint Francis UniversityPolitical Science; Concentration In Pre-Law; Minors In History And Sociology
Frequently Asked Questions about Jennifer Gavin
What company does Jennifer Gavin work for?
Jennifer Gavin works for Novartis
What is Jennifer Gavin's role at the current company?
Jennifer Gavin's current role is Head Inspection Strategic Operations, Global Development Quality.
What is Jennifer Gavin's email address?
Jennifer Gavin's email address is je****@****hoo.com
What is Jennifer Gavin's direct phone number?
Jennifer Gavin's direct phone number is +1 609 452*****
What schools did Jennifer Gavin attend?
Jennifer Gavin attended Temple University, Temple University, Saint Francis University.
What skills is Jennifer Gavin known for?
Jennifer Gavin has skills like Capa Management, Inspection Readiness, Issue Escalation Management, Sop Creation/review, Management, Client Relations, Ich Gcp, Gmp, Quality Assurance, Gcp Auditing, Pharmaceutical Industry.
Who are Jennifer Gavin's colleagues?
Jennifer Gavin's colleagues are Murat Çelikkaya, Dr. Yvonne Schmitt, Nick Riley, Simone Zuehlke, Maja Pavlek, Yi-Ling Chen, 井上貴斗 Inoue Takato.
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