A multi-disciplined, results driven, and goal oriented quality management leader with over twenty years of experience in the regulated pharmaceutical industry. A diverse background that includes all aspects of Quality Assurance (QA) management, Information Technology (IT), and project management. A customer focused and self-motivated team player with a history of working as a leader in team-oriented environments. Successfully lead the implementation of Quality Management Systems, Computer Systems Validation (CSV) projects, and audits to completion, in an efficient and timely manner according to corporate, QA, and business initiatives. A proven track record for attention to detail, innovation, and implementation when it comes to solving problems using root cause analysis.

Highlights:

• Auditing
• Computer Systems Validation
• CAPA
• Quality Systems
• Research and Development
• Pharmaceutical Biotech
• Auditing, Quality Management, Computer Systems Validation, CAPA, Supervision, GMP, 21 CFR Part 11
• Quality
• Quality Assurance
• Good Laboratory Practices
• Software Quality Assurance
• Software Validation