Marianne Lavine

About Marianne Lavine

Personal Brand: Implementing, working with people, promoting solutions with an eye toward innovation.

Experience

1. Director Regional Quality Management Systems, Business Quality North America

   Johnson & Johnson

   Sep 2017 — Present

   On behalf of the Janssen Commercial companies in North America, provide strategic, organizational leadership and decision support for the Business Quality (BQ) organization with regard to Quality Systems.*Responsible for leading/directing the development and implementation of key organizations and process programs across the U.S. and Canada Local Operating Companies (LOC) to ensure effectivity of the Quality Management Systems (QMS).*Continuously monitor the health of the QMS and identify high risk areas, address with CAPA where appropriate.*Lead and support the review input needed for continual deployment of QMS Enterprise standards, BQ cross-sector and pharma sector SOPs to the US LOC.*Evaluate, assess and drive training strategies (including mangement, streamlining training development and deployment).*Ensure the quality systems are in a constant state of readiness for planned and ad hoc regulatory audits or inspections conducted by regulatory bodies, competent authorities or other agencies.*Responsible for monitoring the effectiveness of key Quality Systems as part of the Quality Metrics review for the U.S. and Canada LOCs, recommending actions to address gaps, improve the execution and efficiency of theses systems and prevent future compliance gaps.*Oversees the content for the Quality System Management Reviews (QSMR) for all the U.S. LOC, the Canadian LOC and the NA Region

Education

• University of Michigan School of Nursing

  Bachelor of Science in Nursing, Registered Nursing/Registered Nurse

• University of Michigan

  Bachelor of Science (B.Sc.), Nursing Science

Skills

• Healthcare
• Medical Writing
• Quality Management
• Collaborative Problem Solving
• Change Management
• Managed Care
• Clinical Development
• Neuroscience
• Gxp
• Compliance
• Biotechnology
• Healthcare Management
• Clinical Trials
• Computer System Validation
• Pharmaceutical Industry
• Cross-Functional Team Leadership
• Gastrointestinal Disorders
• Medical Affairs
• Fda 483 Response Authoring
• Burn Intensive Care
• Clinical Supervision
• Management
• Oncology
• Pharmacovigilance
• Cardiovascular Disease
• Process Excellence
• Root Cause Analysis
• Black Belt
• Performance Management
• Regulatory Medical Writing
• Regulatory Audits
• Clinical Intensive Care Unit
• Corrective and Preventive Action (Capa)
• Hospitals
• Regulatory Requirements
• Personnel Management
• Clinical Research
• Capa
• Organizational Development
• Clinical Nursing