Head Of Commercial Quality Turkey

BOEHRİNGER INGELHEİM İLAÇ TİCARET ANONİM ŞİRKETİ

Description:

Head of the Quality function in Turkey which serves HP and AH business units with the following accountabilities:

Responsibilities:

1. Owner of the Quality Management System:

• Establish and maintain the Quality Management System in Turkey.
• Align with the key functions for the continuous improvement of Turkey QMS.
• Lead the Quality Management Reviews (QMR) in Turkey
• Ensure adequate CAPA plans are established and tracked for completion.
• Ensure that initial and continuous training programs are implemented and maintained.

2. GDP responsible towards the authorities

• Manage audits by Corporate or inspections by local Authorities in respect to GMP/GDP.
• Ensure that suppliers and customers are approved.
• Approve any subcontracted activities which may have an impact on GMP / GDP.
• Ensure that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place.

3. Local Pharmaceutical Complaint Officer (LPCO):

• Coordinate and promptly perform any recall operations for medicinal products.
• Owner of the LAC (Local Advisory Committee) ensuring proper escalation of major and critical Product/Quality Defects.
• Ensure that relevant customer complaints are handled effectively on timely manner.

4. Responsible Pharmacist and Product supply support:

• Manage external service providers in all quality relevant aspects during the life cycle of a contract beginning with the issuance until termination to ensure regional/ local supply and manufacture of products or services with acceptable quality, in full regulatory compliance and in accordance with contractual obligations and BI guidelines

      - re-packagers – secondary packaging distributors
      - freight forwarders
      - warehouses
      - graphic offices
      - contract laboratories
      - Co-promotion / Co-Marketing partners
      - Out-licensing partners
      - Outsourced services with GMP/GDP relevance

5. Management of External Service Providers:

• Manage external service providers in all quality relevant aspects during the life cycle of a contract beginning with the issuance until termination to ensure regional/ local supply and manufacture of products or services with acceptable quality, in full regulatory compliance and in accordance with contractual obligations and BI guidelines

      - re-packagers – secondary packaging distributors
      - freight forwarders
      - warehouses
      - graphic offices
      - contract laboratories
      - Co-promotion / Co-Marketing partners
      - Out-licensing partners
      - Outsourced services with GMP/GDP relevance

Requirements:

• Solid experience in quality management
• 4-6 years leadership experience as per below:

      - leading projects

      - leading team

      - leading business/function

• Fluent in Turkish and English
• Good experience in leadership management
• Strong knowledge of international regulations/guidelines concerning GDP/GMP and Quality Assurance
• Very good communication and intercultural skills
• Interdisciplinary thinking and open communication
• Excellent interpersonal skills, assertiveness, decision-making ability