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Director, Distribution & Country Quality, EMEA – Netherlands based

Director, Distribution & Country Quality, EMEA – Netherlands based

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CT19

Our client is a well-established & specialised pharmaceutical company focused on ophthalmology. With sales in over 60 countries, & 4,000 global employees working to deliver life-changing therapies.
 
Role: Director of Distribution & Country Quality (EMEA)
Location: Netherlands or France
Salary: Competitive/DOE + benefits
 
Responsibilities:

  • To lead & drive Quality operations for EMEA distribution operations, ensuring:
  • Effective & efficient organisation, effective implementation of all applicable quality standards, policies & processes
  • Development & implementation of robust, efficient, state-of-the art governance, procedures, processes, systems, & tools across the EMEA distribution network
  • Effective management of any operational quality matter, risk & opportunity, incl. quality reviews
  • Effective management of repackaging/reworking/labelling operations, QC importation testing or any other operation needed to support the business
  • Identification & effective implementation of appropriate improvement plans
  • Proper selection, qualification & quality oversight of third-party distributors & transporters (quality agreements, quality reviews, performance monitoring, risk assessment, continuous improvement, support to inspection, phase-out…)
  • Effective liaison with EMEA Quality, Global Quality or other Product Supply / Commercial Operations entities so as to ensure timely & effective implementation of global processes

 

  • To lead & drive Quality operations within the EMEA commercial network, ensuring:
  • Effective & efficient organisation to best support the company goals & vision
  • Effective implementation of all applicable quality standards, policies & processes
  • Development & implementation of robust, efficient, state-of-the art governance, procedures, processes, systems, & tools across the commercial network
  • All-time inspection readiness, including adequate regulatory inspection preparation, management, & follow-up, & appropriate self-inspection program
  • Effective communication within any local Health Authorities & the country/cluster organisation, making sure that any commitment will properly tracked & closed on time
  • Effective liaison with EMEA Quality, Global Quality or other Product Supply / Commercial Operations entities so as to ensure timely & effective implementation of global processes
  • Appropriate performance management
  • Effective management of any operational quality matter, risk & opportunity, incl. quality reviews
  • Proper selection, qualification & quality oversight of third-party service providers (quality agreements, quality reviews, performance monitoring, risk assessment, continuous improvement, support to inspections, phase-out…)

 

  • Lead quality oversight of NL-based EMEA functions
  • Ensure the companies’ NL branch complies with its duties per any applicable license, incl. possible RP/PRRC role
  • Represent EMEA Quality in global projects & actively participate in the EMEA Quality Leadership Team (QLT), lead cross-functional initiatives, & proactively support other QLT members where needed
  • Lead, organise, manage, develop, & coach the team, fostering the right behaviours & mindset
  • Manage the allocated budge

 
Requirements

  • 12-15 years of Quality experience in pharma companies operating globally
  • 5< years of experience in a multi-site or regional corporate quality role with a focus on distribution & country quality
  • Thorough knowledge & understanding of any applicable GxP & Medical Device-related requirements & regulations
  • Experience in successfully leading cross-functional teams & projects at multi-site or regional level
  • Thorough understanding of distribution, & commercial activities
  • Significant experience in managing regulatory inspections & interacting with authorities
  • Significant experience in managing third-party organisations
  • Strong knowledge of risk management approaches & method

 
 

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Job Overview
Category
Pharmaceutical
Job Location
The Netherlands
Job Type
Permanent
Consultant