Kennis, opleidingen en ervaring:

Opleiding: HBO/ HTS

Stages en werkervaring: Apr.11 – Mar.13, Director International Quality, Emerging Markets, Amgen Europe B.V., Netherlands
• Quality Leadership and strategy on international expansion of Amgen medicinal products into Emerging Central and Eastern Europe, Middle East and Africa, and Latin America.
• Organizational and team/talent development
• Quality operations execution of commercialization activities and international quality system development.

May.10 - Mar.11, Sr. QA Manager, International Expansions, Amgen Europe B.V., Netherlands
• Quality Lead in commercialization of Amgen medicinal products in new countries / Emerging Markets
• Country entry, due diligence and sustaining quality oversight programs in Distributor Territories.
• Building of partnerships with Commercial Distributors, multi-site Amgen organizations and cross-functional teams.



Feb.09 - Apr.10, Regional Quality Director EMEA, Hospira Healthcare B.V., Netherlands
• Strategic leadership of the Commercial and Distribution Quality program of Hospira medicines and medical devices.
• Supply Chain Quality, Supplier Quality and Third Party Manufacturer Quality Programs.
• Batch Release, Quality System and Good Manufacturing Practices (GMP) compliance.
• Post Market Surveillance, product safety, device and pharmacovigilance programs.

Feb. 07 – Jan. 09, Regional Quality Manager EMEA, Hospira Healthcare B.V., Netherlands
• Suppliers (Raw materials, components, APIs, QC Laboratory services, Re-pack sites, IMPs) and electromechanical equipment Service Centres Quality Oversight.
• Third Party Manufacturer Relationships and Quality Oversight.
• Supply Chain and Distribution Quality Systems (warehousing, wholesalers, distributors, transportation).

Jan. 03 – Feb. 07, International Projects/Quality Engineering Manager, Abbott Labs Hospira, Costa Rica
• Supplier Quality / Supplier Relationships.
• Product transfers / international operations expansion Projects.
• Quality Engineering, Corrective Actions and Preventive Actions – Investigations, including customer complaints.
• Quality Metrics and Management Review
• Risk Management for Product Life Cycle – Medical Devices

Jan. 02 – Dec. 02, Plant Quality Assurance Manager, Abbott Laboratories, Dominican Republic
• Business Strategy
• Resource (Budget, Capital, Head Count) Management
• People and organizational development

Jul. 99 – Dec. 01, Manufacturing Quality Manager Abbott Laboratories, Costa Rica
Regulatory Compliance Manager
. Documentation Supervisor, .
• Incoming Quality, in process and final Quality Control
• Process Optimization
• Internal and External Quality Audits
• Product Release / Electronic Batch Records
• SOPs, specifications, BOMs, Batch Records

Jul. 97-Jun 98, Process/Yield/Integration Sr. Engineer, Intel, Costa Rica
• Operations Start up/Technology Design Transfer
• Managed Process Integration and Optimization. Coordinated process change control.
• Developed and managed the Yield Excursion System

May 95- Jun. 97, Laboratory Chief Chemist, Baxter Healthcare, Costa Rica
• Raw materials, compressed air, purified water Quality Control
• Laboratory Operations Management (GLPs)

Opleidingen en cursussen: Education
• B.S. in Chemistry – 1994, Iowa State University, USA. (Fulbright Scholar)
• MBA - Marketing, ( 50% completed ), Universidad Interamericana de Costa Rica

Professional Certifications
• Certified Six Sigma Black Belt, ASQ (American Society for Quality)
• Certified Quality Engineer, ASQ
• ISO 9001 Lead Auditor, BVQI (Bureau Veritas Quality International)

Overige informatie:

Rijbewijs: A,B

Eigen vervoer: Nee

Persoonlijke eigenschappen: Leadership skills complemented with: integrity, adaptability, change agent, results driven, building of strategic relationships, team work, customer service oriented, quality focused, superior communication, speed, entrepreneurial spirit.

Hobby's en interesses:

Gewenste contractvorm: Fulltime