TPM and Technical Transfer Sr.QA Manager-EMEA

The Opportunity

As TPM and Technical Transfer Sr.QA Manager- EMEA , you’ll be responsible for TPM Management and Product Transfer and Technical Support for assigned TPMs.

This position works at Istanbul location in the Established Pharmaceutical Division, where we are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management / central nervous system, and respiratory.

As the TPM Sr.QA Manager, you’ll be responsible for :

• Providing QA support for assigned TPM’s to ensure that safe, efficacious, and quality product can be supplied to Abbott to meet cGMP and other applicable regulatory standards and the appropriate market requirements.
• Responsible for development of Quality Improvement Plan for TPMs remediations, when required.
• Managing TPM activities while driving continuous improvement for TPMs.
• Responsible for Monitoring quality performance for assigned TPMs and ensure requirements per Quality Technical Agreements are adhered / followed by assigned TPMs
• Leading Quality Technical Agreements approval and periodic review
• Primary contact for communication of TPM Quality issues as needed.
• QA support for investigations, trends, complaints, corrective and preventive actions (CAPA), validation support, and product release issues as needed.
• Responsible for maintaining TPM Approved Supplier Listing.
• Responsible for supporting Quality Compliance and improvement initiatives.
• Support new contract manufacturing site approvals must approve all new contract manufacturers for EPD commercial product within responsibility.
• QA Lead for investigations, trends, complaints, corrective and preventive actions (CAPA), validation support, product release issues, PQR review and change control at TPM sites
• QA lead for co-ordination with TPMs and internal cross functional team as support and interfaces for routine Quality requirements like GMP audits, new projects or initiatives.
• Analyzes data, makes decisions or provides recommendations to senior staff regarding quality related issues & crises. Work cross functionally in identifying and resolving technical issues across different EPD regions.
• Recommends and implements changes to the system as the result of changing regulations and / or business needs.
• Coordinates across functional areas, business units, and / or geographies in order to achieve the impact goals.

As Product Technology Transfer Sr.QA Manager

Act as QA Lead for below quality activities during Product Technology Transfer

Required Qualifications

Preferred Qualifications