Commercial Quality Unit (CQU) Head

仕事内容

• Responsible for the overall Commercial Quality activities in a country in alignment with business unit, in order to ensure products are efficiently distributed into the country by meeting company’s, regional and local standards and customer needs.
• Manage the Commercial Quality Unit team as relevant
• Act as Responsible person for the distribution of Medicinal products on the Belgian and Luxembourg market.
• Act as Materiovigilance responsible towards the Belgian and Luxembourg authorities.
  

• Ensure GMP & GDP compliance at the commercial unit and promote quality culture
• Create, maintain up-to-date and distribute Standard Operating Procedures and Working Instructions as per company’s standard and in compliance with national regulations
• Ensure GMP and GDP training at a local level
• Initiate continuous improvement of processes
• Lead Local Cross functional Quality Council
• If applicable, ensure a system is in place to manage and review Product Quality Reviews for local products
• Attend to European monthly quality councils
• Provide the relevant data to the European Commercial Quality local monthly quality metrics
• Ensure necessary processes and procedures are in place for medical device regulations and food-supplements/cosmetics distribution
  

• Market release: Ensure market release from approved suppliers based on batch release documentation and transport conditions documentation
• Distribution: Ensure GDP compliance of the distribution center(s); Approving returns to saleable stock and ensuring the distribution traceability of finished products and returns of products commercialized in the country; Deciding on final disposition of rejected, recalled or falsified products; Implement processes and procedures following narcotics legislation
• Complaints and Recalls: Ensure quality complaints are registered and liaise with manufacturing site to trigger corresponding investigation and adequate corrective actions. Liaise with pharmacovigilance department if necessary; In case of recall ensure local coordination between PhV, medical affairs, regulatory affairs, supply chain, etc. and with EU Qualified person concerned Escalate any critical information to (sub regional) head of commercial quality and issue the final recall report
• Change control, deviations and CAPAs: Administer, maintain and develop systems for change control, deviation and CAPA handling
• Suppliers/customers and 3rd party service providers: Maintain and monitor a list of approved suppliers/customers/providers; Ensure Quality Agreements are drawn up and kept updated with all local suppliers/customers and 3rd party service providers as required
• Subcontracting: Approving any GDP subcontracting activity
• Archiving: Ensure relevant quality related documentation is archived as required
  

• Escalate to sub-Regional Commercial Quality Head critical quality issues raised at local level
• Ensure local deployment of action plan related to quality incidents
• Ensure appropriate communication with local Competent authorities
  

• Ensure permanent authorities inspection readiness in the country
• Host local authorities inspection
• Define inspection CAPA plan and submit it for approval to Sub Regional Commercial Quality Head
• Ensure inspection CAPA plan defined is deployed in due date
• Ensure self-inspection is performed at regular intervals
  

• Establish network in the country with direct and indirect reports
• Participate in periodic local management meetings organized with other supportive functions (Supply chain, Regulatory Affairs, Pharmacovigilance…)
• Regular meetings with local General Manager of Commercial Units to align quality objectives with business objectives and local strategic plans
  

• Manage and lead Commercial Quality Units team members
• Train and provide professional guidance to teams
• Define annual objectives in compliance with annual Sub-Regional Commercial Quality objectives
• Perform annual processes such as performance reviews, compensation, etc., taking into account local business partners input
• Participate in the annual budget elaboration
• Lead periodic face to face meeting with CQU team members and lead periodic local CQU meetings
• Define a delegate as back up
  

• Assure the execution of sub-regional projects coordinated in the country, as applicable
• Support Sub-Regional/Regional Quality initiatives outside the country as needed
• Pharmacist, Doctor, Veterinarian, Chemist, Biologist, Master´s Degree in Pharmacy, Medicines, Veterinary Sciences, Biology, Chemistry or Bio-Medicinal Sciences
• Minimum of 2 year experience as a Quality Manager/RP/QP in a pharmaceutical company or importer/distributor
• Demonstrated knowledge and working experience with government regulations for the country
• In-depth knowledge of pharmaceutical industry as it relates to Quality Compliance
• Working knowledge of pharmaceutical operations.
• In-depth understanding of cGMP & GxP’s regulations
• Experience with development and implementation of Quality Systems and application of risk assessment tools
• Proficient computer skills in current software including MS Office
• Excellent English, Basics French