Jacky Sheehan

About Jacky Sheehan

Extensive experience in drug development across multiple therapeutic areas, including Allergy, Infectious Disease, Oncology, CNS, and CV. Proven record of success in leading teams and managing complex workloads and diverse responsibilities across multiple sites within a matrix environment. Excellent project management skills demonstrated in several high priority programs from candidate recommendation through registration and beyond. Deep experience in recruiting, hiring and direct supervision of other professionals, and development of solutions to address the need of clients and business partners.Specialties: Extensive knowledge of Good Laboratory Practice (GLP) and Regulatory requirements.

Experience

1. Associate Director, Gxp Document Management

   Otsuka Pharmaceutical Companies (U.S.)

   Dec 2021 — Present

   Support the development, implementation, continuous improvement, and documentation of Otsuka Companies’ Quality Management System (QMS)• Support the management of the global, regional and local Policies (POL), Standard Operating Procedures (SOPs) and Working Practices (WPs)• Serve as North American Regional Lead for GxP Document Management• Manage the local OPDC controlled Documents team and cost center• Work as part of the GDM core team to share ideas and improve operation, recommending, supporting, and implementing continuous improvement activities and process and procedure improvements to optimize results and improve quality of delivery in line with quality standards requirements• Act as the deputy of the GSOP Office Lead during absence

Education

• Rutgers University

  Mini-MBA, Biopharma Innovation

• Project Management Institute

  PMP Certification, Project Management

• Seton Hall University

  Bachelor's Degree, Biology

  1979 — 1983

• Mercer County Community College

  AMA Project Management Certification

• Mercer County Community College

  Clinical Development & Regulatory Affairs Certification

Skills

• Pharmaceutics
• Drug Discovery
• Cross-Functional Team Leadership
• Biotechnology
• Management
• 21 Cfr Part 11
• U.s. Food and Drug Administration (Fda)
• Good Laboratory Practice (Glp)
• Program Management
• Gxp
• Glp
• Regulatory Affairs
• Lifesciences
• Project Planning
• Clinical Development
• Project Management
• Regulatory Submissions
• Software Documentation
• Therapeutic Areas
• Leadership
• Drug Development
• Gcp
• Biopharmaceuticals
• Operations Management
• Customer Support
• Infectious Diseases
• Life Sciences
• Good Clinical Practice (Gcp)
• CRO
• Pharmaceutical Industry
• Sop
• Fda
• Regulatory Requirements