Sharon Bloom-Sigmund

About Sharon Bloom-Sigmund

Highly motivated and detail-oriented Senior Project / Program and Validation Manager with more than 20 years of experience in both life sciences (pharmaceutical and device) and consulting industries. Direct experience with a significant number of business and scientific applications. Proven leadership ability, excellent interpersonal, problem-solving, organizational, communication, and facilitation skills coupled with a strong work ethic. Ability to work in a team environment in addition to proficiency in negotiation and planning.Specialties: • Successful management of diverse teams. • Expertise in program and project management. • Proficient in application development and implementation of technology solutions. • Experience in providing significant cost savings to business. • Very familiar with regulatory requirements.

Experience

1. Project Manager

   QPharma, Inc.

   Oct 2016 — Present

Education

• Kean University

  Bachelor of Science, Accounting

  1988 — 1992

• Rutgers University

  MBA, Pharmaceutical Management

  2000 — 2004

• Chubb Top Gun

  Technical, Programming

  1997 — 1998

Skills

• Gmp
• Quality System
• Quality Systems
• V&V
• Project Portfolio Management
• Project Planning
• Negotiation
• Change Control
• Cross-Functional Team Leadership
• Technology Transfer
• Life Sciences
• Program Management
• U.s. Title 21 Cfr Part 11 Regulation
• Manufacturing
• Leadership
• Biotechnology
• Team Leadership
• Vendor Management
• Budgets
• Management
• Team Building
• Gxp
• Quality Auditing
• Medical Devices
• Validation
• Process Improvement
• Problem Solving
• Change Management
• 21 Cfr Part 11
• Pharmaceuticals
• Regulatory Requirements
• Regulatory Affairs
• Lifesciences
• Development & Delivery of Training
• Quality Management
• Testing
• Project Management
• Software Documentation
• Sdlc
• Computer System Validation