HG

Heather Groves

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Technology Compliance Manager, QA at Parexel | Raleigh, North Carolina, United States
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About Heather Groves

  • Heather Groves is a seasoned Principal Technology Auditor at Parexel, where she leverages her extensive background in Life Sciences Quality Assurance and Regulatory Compliance to uphold the highest standards of quality in the pharmaceutical industry. With a proven track record of ensuring compliance with GxP...
    Heather Groves is a seasoned Principal Technology Auditor at Parexel, where she leverages her extensive background in Life Sciences Quality Assurance and Regulatory Compliance to uphold the highest standards of quality in the pharmaceutical industry. With a proven track record of ensuring compliance with GxP regulations and ISO 9001 standards, Heather plays a pivotal role in shaping audit programs that address both internal and external systems, IT security, and supplier management. Her analytical skills enable her to conduct thorough audits, identifying potential areas of concern and prioritizing them effectively to mitigate risks. In her current role, Heather acts as the QA Lead for critical audit initiatives, providing invaluable peer review feedback on colleagues' audit reports to foster a culture of continuous improvement within the organization. Her expertise in quality management and quality auditing is further demonstrated through her active participation in Serious Breach discussions, where she collaborates with cross-functional teams to address compliance issues and implement corrective actions. Additionally, Heather is instrumental in reviewing technology-adjacent Standard Operating Procedures (SOPs), ensuring that they align with regulatory expectations and industry best practices. Heather’s proficiency in both Agile and Waterfall methodologies allows her to adapt to various project environments, ensuring that quality assurance processes are seamlessly integrated into the development lifecycle. Her commitment to maintaining industry-leading standards of quality and compliance not only enhances Parexel's reputation but also contributes to the overall integrity of the life sciences sector. With her deep understanding of data management and regulatory frameworks, Heather Groves continues to be a driving force in advancing quality assurance practices within the industry.
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  • Heather Groves Work

    • Technology Compliance Manager, QA at Parexel in February 2022 to Present
    • QTC Principal Auditor at endpoint Clinical in May 2020 to February 2022
    • QTC Sr. Auditor at endpoint Clinical in April 2019 to April 2020
  • Heather Groves Skills

    • Regulatory IntelligenceSupplier AuditsAnalytical Skills
      Internal AuditsGenerative AI ToolsArtificial Intelligence (AI)Data ManagementData GovernanceAuditing21 CFR Part 11Computer System ValidationPharmaceutical IndustryQuality AssuranceValidationCROSOPGxPGCPClinical TrialsFDAITILCAPAQuality ManagementCTMSClinical DevelopmentInternal AuditTechnical WritingSharePointEDCICH-GCPClinical Data ManagementRegulatory SubmissionsQuality AuditingProcess ImprovementManagementCOBITStandards ComplianceIT Risk ManagementExternal AuditIT AuditSoftware Quality AssuranceGAMPAgile & Waterfall MethodologiesVendor AuditISO 27001Change ManagementSoftware DocumentationRegulatory RequirementsISO 9001ICH E6 GCPBusiness Process ImprovementAnnex 11ICHRisk ManagementStandard Operating Procedure (SOP)U.S. Title 21 CFR Part 11 Regulation

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  • About Heather Groves's Current Company

  • Frequently Asked Questions about Heather Groves

    • What is Heather Groves email address?
      Email Heather Groves at c***s@parexel.com. This email is the most updated Heather Groves email found in 2024.
    • How to contact Heather Groves?
      To contact Heather Groves send an email to c***s@parexel.com.
    • What company does Heather Groves work for?
      Heather Groves works for Parexel
    • What is Heather Groves's role at Parexel?
      Heather Groves is Technology Compliance Manager, QA
    • What is Heather Groves's Phone Number?
      Heather Groves's phone (704) ***-*480
    • What industry does Heather Groves work in?
      Heather Groves works in the Pharmaceutical Manufacturing industry.

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