Lauren Crane

About Lauren Crane

Committed to revolutionizing healthcare and pharmaceuticals through visionary leadership…

Experience

1. Executive Director, R & d Quality, Head of Medical Governance

   Gilead Sciences

   Aug 2022 — Present · Parsippany, NJ, US

   Hired to establish and lead a new Medical Governance Quality function, aligning GxP standards with large pharma operational expectations. Built and implemented quality controls, standards, and processes to support the transition toward enterprise-level compliance. Serve as a critical link between business, R&D, compliance, and operations to enhance quality execution, streamline risk management, and strengthen inspection readiness. Oversee and expand a team responsible for GxP Quality oversight (GCP, GVP, GMP, RWE), regulatory compliance, safety governance, and enterprise risk assessments. Partner with cross-functional stakeholders across global operations to drive process harmonization, embed a proactive quality culture, and ensure organizational adherence to evolving regulatory expectations.Led a global team delivering expert quality and compliance support to ensure regulatory adherence across research activities, pharmacovigilance operations, and medical affairs initiatives. Designed and implemented global quality excellence standards for study execution across affiliate markets, establishing consistent operational frameworks, controlled documents, vendor oversight and training programs.Provided executive Quality Management System (QMS) leadership and subject matter expertise during US and international regulatory inspections, ensuring aligned communications with FDA, EMA, and other global agency requirements resulting in reduced inspection findings and enhanced regulatory confidence.Developed advanced quality analytics, implemented proactive monitoring and quality control methodologies to identify emerging risks early in research processes.Designed and implemented targeted training programs. Provided quality oversight and strategic support in the implementation and management of vendor partnerships for study execution, in alignment with regulatory standards, quality agreements, and consistent performance monitoring to mitigate risk

Education

• City University of New York-John Jay College of Criminal Justice

  Master's Degree

• Iona University

  Bachelor of Science - BS

Skills

• Pharmaceutical Industry
• Sop
• Fda
• Quality System
• Clinical Trials
• Biotechnology
• Validation
• CRO
• Oncology
• Regulatory Affairs
• 21 Cfr Part 11
• Medical Devices
• Capa
• Gcp
• Biopharmaceuticals
• Glp
• Pharmacovigilance
• Gmp
• Quality Assurance