Informacje o stanowisku

• Oversee affiliate operations to ensure full compliance with GxP standards, company quality policies, and local regulations.
• Collaborate closely with affiliate leaders to proactively identify and address issues.
• Drive continuous improvement by conducting routine self-assessments, managing CAPAs (Corrective and Preventive Actions), and implementing a Quality Plan.
• Take responsibility for local product quality issues, escalating concerns to regional quality leadership and affiliate management, and leading any necessary local actions (e.g., recalls, counterfeit product management).
• Ensure accurate completion of operational quality tasks, including deviation management, change control, procedure review/approval, and maintenance of the Quality Plan.
• Work with the Responsible Person (or act as one) to verify compliance with Wholesale Distribution Authorization requirements.
• Oversee distribution, product release, and warehousing in alignment with company and regulatory standards, including management of returns, recalls, and product reintegration.
• Initiate notifications to management and implement product holds or quarantines as necessary.
• Analyze and report on Quality metrics, identify trends, and lead continuous improvement initiatives related to deviations and customer complaints.
• Develop and coach team members through impactful training programs, performance evaluations, and leadership development.
• Adhere to company policies on Quality, Code of Conduct, anti-discrimination, and Health, Safety, and Environment (HSE).
• Manage GMP+ tasks such as quality manual maintenance, annual inspections, mock recalls, and participation in HACCP teams.
• Supervise the Central and Eastern Europe (CEE) Quality Team.
   

• Ensure the implementation and maintenance of a quality management system.
• Oversee authorized activities, ensure accurate records, and implement training programs.
• Manage and execute product recalls effectively.
• Handle customer complaints and approve suppliers and customers.
• Approve subcontracted activities affecting Good Distribution Practices (GDP).
• Conduct regular self-inspections, ensure CAPAs are implemented, and maintain records of delegated duties.
• Decide on the final status of returned, rejected, or falsified products, including approval for returns to saleable stock.
• Comply with additional legal requirements for certain products and manage deviations by implementing and monitoring CAPAs.
   

• Master’s degree in Pharmacy or Veterinary Medicine.
• Fulfillment of the requirements outlined in Article 84 of the Polish Pharmaceutical Act of 2001 to qualify as a Responsible Person in Poland.
• Proven leadership and influence in a cGxP (current Good Practices) environment, ideally in a Quality role.
• Ability to lead and collaborate effectively, with experience in stakeholder management.
• Strong communication, presentation, and facilitation skills. 
• Skilled in regulatory inspections, audit management, and responses to health authorities.
• Analytical and investigational expertise. 
• Excellent organizational and strategic planning skills.
• Fluency in Polish and English (written and spoken).
• Knowledge of inventory management is a plus.
   

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

Hays Poland sp. z o.o. is an employment agency registered in a registry kept by Marshal of the Mazowieckie Voivodeship under the number 361.

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