Lauren Crane Email and Phone Number
Committed to revolutionizing healthcare and pharmaceuticals through visionary leadership in GxP compliance, quality assurance, and innovative program development, while championing ethical practices and cross-functional collaboration.As an influential and strategic medical quality and compliance executive in the pharmaceuticals and healthcare sectors, I excel in GxP compliance, healthcare compliance, risk management, quality assurance, ethics, and innovation. With a proven track record in program development, training, and team building, I have leveraged my expertise in stakeholder management and cross-functional collaboration to support innovation and integrations across various specialty areas. Adept at connecting legal, business stakeholders, and operations, I simplify complex concepts into manageable processes, enhancing team cohesion. My commitment to building robust quality programs and compliance functions is matched by my dedication as a persistent leader and mentor. A few major accomplishments across my career include:• Developed and led an extensive Corporate Integrity Agreement compliance training program at Boehringer Ingelheim Pharmaceuticals, ensuring comprehensive adherence and enhancing overall organizational compliance.• Centralized and standardized evaluation of healthcare provider arrangements at Gilead Sciences, dramatically improving organizational culture and compliance understanding across departments.• Spearheaded Medical support of CAR T therapy at Novartis Pharmaceuticals, leading innovation and ensuring compliance with stringent regulatory standards, resulting in the successful implementation of novel treatment.I am excited to expand my professional network and see what the future may hold. If you would like to connect, please contact me at lecrane9598@aol.com.AREAS OF EXPERTISE Medical Governance & LeadershipInnovative Program DevelopmentMedical Quality & ComplianceGxP Compliance ExpertiseStakeholder ManagementTraining & DevelopmentInnovation & IntegrationClinical Trial OversightMentorship & TrainingQuality Strategy
Gilead Sciences
View- Website:
- gilead.com
- Employees:
- 14647
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Executive Director, R And D Quality, Head Of Medical GovernanceGilead SciencesYorktown Heights, Ny, Us
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Executive Director, Head Of Medical GovernanceGilead Sciences Aug 2022 - PresentParsippany, New Jersey, United StatesHired to establish and lead medical governance quality function, implementing controls, standards, and processes to align with large pharma operations. Enhance compliance efficiency and streamline risk management, overseeing $1M budget and team of 4. Drive cross-functional collaboration to foster quality-focused mindset and support healthcare compliance, GxP quality, and risk assessments.• Centralized and standardized healthcare provider arrangement evaluations, ensuring adherence to government compliance expectations, and received Key Contributor Award for establishing comprehensive medical governance program.• Spearheaded stakeholder management and cross-functional collaboration, dramatically improving organizational culture and compliance understanding through targeted training and persistent, forward-thinking leadership.
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Executive Director Business Quality, Innovation And Oncology Erc StrategyNovartis Oncology Mar 2022 - Aug 2022Promoted to lead innovation segment, managing groundbreaking projects like new treatment launches and major merger integrations. Directed Oncology Business Unit's compliance and audit strategies, including CIA auditing, developing monitoring plans, and managing risk assessments. Built partnerships and drove collaboration with agencies.• Developed and executed novel compliance program, significantly improving quality management across US Oncology Medical Affairs, Commercial, Patient Support Services, and additional departments at Novartis Pharmaceuticals.• Led the development and successful launch of CAR T therapy, ensuring strict regulatory compliance and achieving groundbreaking treatment introduction. -
Director Us Oncology, Ethics Risk ComplianceNovartis Sep 2014 - Mar 2022One Health Plaza, East Hanover NjRecruited to support oncology business unit as compliance partner, adapting to dynamic environment shaped by acquisitions and innovations. Collaborated with VP leads across commercial and medical affairs divisions, gaining advanced knowledge in solid tumors, hematology, rare diseases, and radioligand therapies.• Led high-priority project for president of oncology, engaging critical accounts and stakeholders, while crafting effective strategies and tools to support field teams and ensure regulatory compliance.• Integrated 2 additional corporate integrity agreements, building trusted relationships and ensuring comprehensive compliance across business units that eventually led to earning industry recognition. -
Associate Director Business Partner Ii, Ethics And Compliance Research Development And MedicalBoehringer Ingelheim Nov 2013 - Sep 2014Ridgefield, CtPromoted to integrate and manage Corporate Integrity Agreement (CIA), establishing proactive compliance framework. Provided strategic compliance guidance to various departments and business units, ensuring proactive compliance in planning and execution. Managed Research Development & Medical/RA Investigation Committee, overseeing non-compliant investigations and corrective actions. Liaised with BI GmbH to ensure adherence to US laws and regulations.• Developed and led comprehensive CIA compliance training program, equipping teams with essential knowledge and practices, while serving as key leadership team member.• Collaborated with GCP Quality Management to oversee clinical trials, prepare for FDA audits, and develop risk-based monitoring and audit plans as CIA compliance SME. -
Associate Director, Ethics & Compliance, Research & Development/ MedicalBoehringer Ingelheim May 2011 - Nov 2013Boehringer Ingelheim*Assist in strategic planning for Medicine/ DRA activities with the goal of providing compliance expertise and advice to ensure planning is efficient. *Provide compliance expertise to applicable department leaders, develop policies, processes and procedures that support business activities.*Developed monitoring of key business activities for proactive compliance management. Execute action plans for identified CAPAs (Corrective and Preventative Actions) and monitor established controls after implementation. Analyze auditing results and recommend improvements.*Manage the RD& M investigation committee to investigate non-compliant activity and ensure appropiate corrective actions are implemented.
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Pharmacovigilance Compliance ManagerBoehringer Ingelheim Aug 2006 - May 2011Ridgefield , CtOversaw compliance for IND and NDA adverse event reporting, managed CRO project operations and contractual compliance, and coordinated global audits. Developed and led quality assurance program, ensuring adherence to FDA and EMA regulations for drug safety operations, and contributed to global drug safety executive committee.• Restructured department training by developing SOPs, work instructions, and job aids, significantly improving compliance and managing FDA audit presentations.• Implemented CAPA system to optimize pharmacovigilance processes, enhancing quality execution through collaboration with CROs.
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Manufacturing ManagerAmerican Diagnostic Corporation Aug 2005 - Aug 2006Stamford, ConnecticutManaged manufacturing team producing over 300 pharmaceutical products. Developed and implemented a quality management system, optimizing daily operations, ensuring timely product delivery, and conducting routine quality audits.• Ensured 100% compliance with FDA, ISO9001:2000, and ISO13485 standards, focusing on achieving flawless certifications. -
International Quality Assessment ManagerTepnel Lifecodes Corp Jun 1998 - Aug 2005Stamford, Connecticut*Manage a team that manufactured and distributed the Forensic International Quality Assessment Scheme (IQAS) Clinical Proficiency Test Kits worldwide. This included development and maintenance of all standard operational procedures (SOP’s), manufacturing procedures (GMP’s), quality control Procedures (QCP’s), and batch records to assure that all procedures adhered to ASCLD, ISO 9001:2000, and ISO 13485 regulations.*Track and maintain engineering changes, standard operating procedures, test methods, specifications, and masterbatch records. Develop and maintain C of A’s and resolve quality issues. Design and execute validation studies for new products and materials.*Manage the administrative functions of the IQAS Proficiency Program comprised of seventy national and international forensic laboratories. Including performing audits, preparation of quarterly reports, cost analysis, management of external laboratory quality control contracts.*Report scientific data using a Microsoft Access program to compile and analyze results. Emphasize discrepant or adverse events for review and corrective action by ASCLD.*Manage the manufacturing of Effipure, oligo polyacrylamide gel production, and delivery for the clinical study distribution of colon cancer screening test. Maintain and update documentation for compliance with FDA, ISO 9001:2000 and ISO 13485 standards. -
Sr. Forensic ScientistLifecodes Corporation Jul 1987 - Jun 1998Stamford, Connecticut*Manage a staff and ensure maintenance of daily workflow including: tracking receipt of samples, assigning casework to scientists, ensuring that reports are expedited.*Management of standard operation procedures, protocols and laboratory policies.*Analyze forensic and paternity biological evidence for DNA testing.*Performed and interpreted both RFLP and PCR tests.*Testified in over 100 criminal cases nationwide.
Lauren Crane Education Details
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Forensic Science -
Biology, General
Frequently Asked Questions about Lauren Crane
What company does Lauren Crane work for?
Lauren Crane works for Gilead Sciences
What is Lauren Crane's role at the current company?
Lauren Crane's current role is Executive Director, R and D Quality, Head of Medical Governance.
What schools did Lauren Crane attend?
Lauren Crane attended City University Of New York-John Jay College Of Criminal Justice, Iona University.
Who are Lauren Crane's colleagues?
Lauren Crane's colleagues are Destiny Chavez, Kamil Mrowiec, Na-Ri Oh, Jiaqi Liu, Janay Jones, Felix Anaele, Chad Miller.
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Lauren Crane
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Lauren Crane
I Help Ambitious Professionals In Tech Navigate Career Transitions With Clarity And Confidence | 200+ Success Stories And Counting | Former Executive Tech Recruiter Turned Career CoachSan Francisco, Ca
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