Associate Director Quality

Associate Director Quality

Teva

Hafnarfjordur, Iceland

Your role

The Associate Director Quality has the overall responsibility for planning, budgeting, resource management and direction of the quality function for all out licensing agreements for Medis. The incumbent must be capable of establishing sustainable and collaborative relationships with internal and external customers.

The Associate Director Quality is a Medis Responsible Person and a Qualified Person and is consequently responsible to ensure compliance with Good Distribution Practice (GDP) guidelines and current Good Manufacturing Practice (cGMP).

Your duties and responsibilities

  • 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 Teva standard and in compliance with national regulations;
  • Ensure GMP and GDP training at a local level;
  • Lead Local Cross functional Quality Council;
  • Attend to European monthly quality councils;
  • Provide the relevant data to the European Commercial Quality local monthly quality metrics;
  • Ensure quality complaints are registered and liaise with manufacturing site to trigger corresponding investigation and adequate corrective actions. Liaise with pharmacovigilance department if necessary;
  • Administer, maintain and develop systems for change control, deviation and CAPA handling;
  • 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;
  • 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 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);
  • 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;
  • Assure the execution of sub-regional projects coordinated in the country, as applicable;
  • Support Sub-Regional/Regional Quality initiatives outside the country as needed.

Your Qualifications

Education

  • Master´s Degree in Pharmacy, Medicines, Biology or an equivalent combination of education and experience to the functional role;
  • Post-graduate or Doctoral degree in Pharmacy, Medicines, Biology or similarly related fields of specialization would be an advantage.

Experience

  • Proven experience as a Quality Manager/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.

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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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