Professional Summary Self-motivated, energetic and effective leader with 13+ years of experience (8Years of leadership/managerial role) in quality assurance in pharmaceuticals, biologics, Complex injectables, Oncology and combination products. Proven to successfully design and implement quality systems and drive positive change in fast paced environments. Decisive leader who will apply initiative and innovation to establish and sustain successful performance both as individual contributor and team player. Maintain strong verbal and written communication with employees at all levels. Exceptional planning, time management, and organization skills with expertise in auditing to FDA quality systems. Proficient with Trackwise, Document compliance manager, SAP, LIMS, LMS, Workday and Microsoft Office. I do my best work in challenging situations.

Highlights:

• Management
• Oncology
• Manufacturing
• Quality Assurance
• Test
• Quality
• Quality Management
• Documentation
• Audit
• Filing