Over 20 years in pharmaceutical and biotech *10 years research *U.S. and International Quality and Regulatory *Quality Auditing, domestic and international *Batch Review and Product Release *Investigations and CAPA *Contract Manufacturing Liaison, domestic and international *Successful building of Quality Systems *CMC and IMPD experience *Clinical Quality management *Quality Control, analytical development *Continuous quality improvement using key performance indicators and metrics *Facility Design, validation, and startup

Highlights:

• Quality
• Regulatory
• auditing
• Document Control
• Vendor qualification
• GXP
• Device
• Biologics