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
• Years of Experience
No experience preference
• Level of Education
Bachelor’s(Graduate)