About the job:
Country Quality Head will lead and manage the implementation and maintenance of the Country Quality system, embarking all concerned country functions (responsible for GxP and health-regulated activities), ensuring safe and efficient quality products, with associated information & services are available to meet patients’ and customers’ needs.
Country Qualit Head acts as deputy of Qualified Person for distribution.
Main Responsibilities
Define, implement, manage and control a Country Quality system for GxP and health-regulated activities in compliance with Sanofi standards and with applicable local regulatory requirements.Enhance Quality culture & promote Quality mind-set into the country governance, working principles and ways of operating.Ensure quality oversight on country local contract manufacturers, distributors and GxP service providers.Act as contact person for local health authorities for any quality related topic or issue linked to quality of product in Ukraine.Assure that a process for management of GxP documents and records is in place in all GxP processes, considering data integrity principles.Organize and manage information sharing, training sessions or programs related to processes under the responsibility of country quality for concerned country associates.Manage country regulatory inspections under quality responsibility, GMP regulatory inspection on manufacturing sites and provide support to other GxP country functions in country regulatory inspections for processes in their respective areas of responsibilities (e.g PV)Ensure inspection readiness and continuous quality improvement.As deputy of QP ensure compliant market batch release according to local regulationAssure quality of products is managed according to Sanofi standard and local regulation (quality complaints, Product quality review, batch recalls, quality defect reporting to health authorities).Establish and approve quality agreements with manufacturers, distributors (internal & external).Connect and advocate externally with pharmaceutical associations, keep up to date with local regulation under quality responsibility.Lead Ukrainian quality team.About you:
University qualification: Completed higher education (master level). Degree in Pharmacy is preferred, other degrees: Chemistry, Chemical Technology and Engineering, Biotechnology and Bioengineering, Biomedical Engineering, Biology or another life science discipline.Min 5 years’ experience with Quality Management System in pharmaceutical industry (distribution and re-packaging experience is advantage).Solid knowledge of Good Distribution/Manufacturing guidelines/legislation. Knowledge of other GxP guidelines would be an advantage.Ukrainian and English – advanced level both oral and writtenExperience in commercial operations in pharma is advantage.Experience with batch release is advantage.Strong leadership and interpersonal skills with the ability to develop strong teams and the individuals within department.Familiarity with financial budgeting, costing and planning. Ability to foresee and respond to issues/opportunities in a timely and effective manner.#LI-EUR
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