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Online Resumes with "FDA EMA"



Quality Assurance Director - 20 Years of Experience - Near 27962

Summary A Quality Assurance leader with 25+ years of cGXP expertise working in the Biotech and Commercial Pharma manufacturing industry. Extensive experience working directly with USA and EU CMOs/CTLs dealing with process drug development/ process troubleshooting, process validation, inspection readiness, and IMP distribution/ disposition. Successful FDA/EMA/ROW inspections and approval history with expertise leading global...

Tags for this Online Resume: Management, Utilities, CMOS, Audit, Quality Assurance, Test, Pharmaceutical, Process Engineering, Engineering, Packaging

Featured Profile

OPERATIONS & BUSINESS DEVELOPMENT EXECUTIVE in Washington, DC Area

Diverse accomplishments in leading business development, marketing, operations and performance improvement for a division of $9.7B IQVIA, a large non-profit and a well-respected law firm. Led an underperforming clinical research startup through turnaround to a $20M buyout/acquisition. Strengths in driving efficiency, controlling costs, managing finance & legal matters and building profits. Can contribute by: ρ Directing s...

Ideal Companies: PPD, Covance, Perexel, Delloite, PWC, E&Y., Interested in biotech consulting firms, biotech firms, business consulting firms, and venture capital firms, in particular.

Tags for this Online Resume: Business Development, Accounting, Clinical Research, Consulting, Financial, Financial Reporting, Research, Arbitration, Legacy, Legal