Country Quality Manager

Job Description Summary

• To ensure that the product, processes and procedures conforms with GxP and local specifications and that production activity is compliant with Novartis quality policy and GxP requirements.
• To ensure that relevant documentation is up-to-date and archived correctly. Ensure “state of the art” GxP know-how and future trends in the field of GxP

Major Accountabilities

• Manage the implementation and maintenance of a local Quality Management System that complies with local regulatory requirements and the Novartis Quality Manual and policies.
• Ensure timely implementation of updates to applicable local guidelines and requirements, including GMP, GDP, and barcode and 2D barcode requirements for human medicinal products.
• Fulfil the duties and responsibilities of the Qualified Person for the Farmanova entity, including performing batch release checks and approving relevant products.
• Perform release activities for supporting clinical products.
• Approve artwork changes for Farmanova products.
• Collaborate with all Country functions responsible for GxP and health-regulated activities to ensure the efficient and effective operation of the Country Quality System.
• Establish and maintain effective communication with local Health Authorities and the Country organisation, ensuring that all commitments are appropriately tracked and closed on time.
• Manage product recalls/ mock recalls in accordance with local regulatory requirements and the Novartis Quality Manual, and support or participate in related activities as required.
• Participate in the evaluation and investigation of quality deviations and complaints, ensuring that appropriate corrective and preventive actions (CAPAs) are established.
• Lead escalation processes and follow up on required actions.
• Review and approve standard operating procedures (SOPs).
• Manage changes that affect or could affect product quality and serve as the Change Management Lead for the Country organization.
• Perform Marketing Authorisation Holder (MAH) reviews of relevant Annual Product Quality Reviews (APQRs), prepare the annual APQR plan, evaluate trends, and follow up on actions.
• Ensure the annual Quality Plan is prepared, and its actions are followed through to completion.
• Lead Quality System and GMP audits conducted by Health Authorities, Novartis Global functions, or outsourced service providers.
• Lead training and self-inspection activities in accordance with local and global requirements.
• Ensure compliance with quality risk management requirements, including the identification, anticipation, and assessment of quality risks; development and implementation of appropriate action plans; and preparation of the annual risk assessment plan and report.
• Report quarterly Key Quality Indicators within the scope of responsibilities, monitor performance, and ensure that gaps are appropriately addressed to mitigate risk.
• Prepare annual and quarterly review reports, including the Annual Quality Review Report, Training Plan Report, and Business Review Meeting materials.
• Provide quality oversight of the third-party warehouse and maintain effective collaboration with relevant partners.
• Lead vendor management activities, including quarterly review meetings, preparation of the Approved Supplier List, qualification processes, and Quality Assurance Agreement (QAA) preparation.
• Actively drive operational excellence projects in alignment with global process streams and the Country Quality strategy.
• Ensure implementation and maintenance of the ISO 9001:2015 Quality Management System within the Türkiye Country organization.
• Act as the Quality Operations Partner (QOP) single point of contact within the Country Quality organization.
• Serve as Culture Ambassador Lead for Country Quality Türkiye within the region.
• Act as deputy to the Country Quality Head Türkiye.

Key Competencies

• Proactive mindset
• Resilience and adaptability
• Business acumen
• Curiosity and continuous learning
• Sound judgement and decision-making
• Strong project management skills

Role Requirements

• University degree in Pharmacy, Chemical Engineering, Chemistry, or a related discipline.
• Advanced written and verbal communication skills in English are required.
• At least 6 years of Quality experience within the pharmaceutical industry.
• At least 2 years of experience at a pharmaceutical manufacturing site in Quality Control, Quality Assurance, or Manufacturing Quality.
• Strong knowledge of the regulations, guidelines, and good practices applicable to Country organisation operations.
• End-to-end process orientation and a continuous