Associate Director Third Party Operations Quality EMEA

Associate Director Third Party Operations Quality EMEA

Teva

Sofia, Bulgaria

We are looking for qualified and motivated candidate to join our Third Party Operations Quality EMEA (TPQ EMEA) department on the position Associate Director Third Party Operations Quality EMEA Medical Devices, Cosmetics & Food Supplements, based in Sofia.

Main Responsibilities

  • Responsibility for the release of medical devices as legal manufacturer (Merckle)
  • Securing that the manufacturing and testing of 3rd Party products, is in compliance with applicable GMP requirements, norms and regulations and registered technical documentations/dossiers
  • Ensuring that a proper Quality Management System is in place and used at the 3rd Party manufacturer and the related internal Operation areas. The job holder could refer to written provisions belonging to the superior responsibility
  • Securing that the assessment of Quality issues (related to OOS (LIR) or deviation ( MDR, regulatory; non Compliance, Audit findings) of medical devices, cosmetic products and food supplements where Merckle acts as legal manufacturer or responsible person is done according global Teva requirements
  • Ensuring highly qualified vendor management system in terms of Quality through collaboration with suppliers and other in-house functional stakeholders (e.g. SRMs, Procurement, Supply Chain, TSA and RA)
  • Responsibility for the supervision of products where Merckle is the Legal Manufacturer/Responsible Person/Distributor (medical devices cosmetics, food supplements) through the entire life cycle with regard to quality and regulatory compliance. Taking actions needed to maintain the product quality and compliance
  • Participation at the planning of the budget (AOP) and monitoring the budget in the area of responsibility
  • Ensuring the coordination of all quality assurance aspects and analytical activities for launches taking place in the Quality unit of TEVA,at contract labs, 3rd Party Manufacturers/other vendors and/or other divisions of Teva for non-medicinal products (medical devices, cosmetics, food supplements)
  • Securing an optimal process-oriented organization between the sub-processes and interfaces to other business units with the inclusion of all up- and downstream processes
  • Ensuring a high level of synergy and an optimal collaboration, particularly with other quality units contributing the quality assurance of OTC 3rd Party Products/Medical Devices
  • Review of regulatory requirements for medical devices, cosmetics and food supplements on regular basis and application on products where Merckle is the legal manufacturer/responsible person or distributor
  • Leadership, motivation and development employees according to the Leadership Framework and Guidelines of Teva

Main Requirements

  • Completed natural science degree or comparable qualified education
  • More than 10 years of experience in the fields of manufacturing, quality control/analytics, and/or quality assurance preferably in the pharmaceutical industry
  • Detailed knowledge in international pharmaceutical and related regulations and guidelines; wide range of expertise in different pharmaceutical manufacturing processes and analytical methods
  • Know how in KPI and processes flows and reporting lines
  • Proven experience in the fields of negotiations with international suppliers and participation in audits and regulatory inspections
  • Specialized in-depth/wide range of expertise, the person is recognized as expert in an own area within the organization and possesses proven leadership qualities
  • Ability to serve as best practice quality resource within and outside own discipline
  • Ability to lead departments with diversity functional groups
  • Understanding of how to recognize business opportunities and to implement them to major achievements
  • Ability to perform without appreciable direction
  • Excellent organizational and interpersonal skills
  • Strong computer skills (MS Office, SAP and TrackWise) are desired
  • Fluent business English skills both written and spoken

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© EuroJobsites 2021

EuroJobsites is a 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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