CEE Quality Manager, Responsible Person

3 tygodni temu

Warszawa, Polska HAYS Pełny etat
CEE Quality Manager, Responsible Person
Warszawa
NR REF.: 1190570

** Functions, Duties, Tasks:**
  • 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.
     
**Responsibilities as Responsible Person (RP):**
 
  • 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.
     
**Requirements:**
 
  • 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 you39re interested in this role, click 39apply now39 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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