Country Quality Leader & Qualified Person

TR01 (FCRS = TR001) Novartis Sağlık, Gıda ve Tarım Ürünleri San. Ve Tic. A.Ş.; Ataşehir; On-site; TRY 800,000 - 1,200,000; Full time

Job summary

Novartis Sağlık, Gıda ve Tarım Ürünleri San. Ve Tic. A.Ş.

Türkiye seeks a senior Quality professional to ensure GxP and local specifications are met, maintain documentation, and oversee quality systems. You will act as Qualified Person for Farmanova, perform batch release checks, and manage local regulatory interactions with health authorities. You will lead audits, CAPA, risk management, and annual quality planning across the country organization, driving continuous improvement and operational

Qualifications

• University degree in Pharmacy, Chemical Engineering, Chemistry, or 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-improvement mindset.
• Strong knowledge of current Good Manufacturing Practice (cGMP), relevant GxP requirements, and pharmaceutical distribution processes.
• Ability to manage multiple priorities and consistently meet deadlines.
• Excellent interpersonal, communication, and presentation skills.

Responsibilities

• Manage the local Quality Management System that complies with local regulatory requirements and Novartis policies.
• Ensure timely updates to GMP, GDP, and barcode requirements for human medicinal products.
• Fulfil the duties and responsibilities of the Qualified Person for the Farmanova entity, including batch release checks.
• 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 efficient operation of the Country Quality System.
• Establish and maintain communication with local Health Authorities and the Country organisation, tracking commitments to closure.
• Manage product recalls/mock recalls per local regulations and quality manual.
• Participate in evaluation of quality deviations and CAPA establishment.
• Lead escalation processes and follow up on actions.
• Review and approve SOPs.
• Manage changes affecting product quality and serve as Change Management Lead.
• Conduct MAH reviews of APQRs and prepare annual APQR plan.
• Ensure annual Quality Plan and its actions are completed.
• Lead Quality System and GMP audits by Health Authorities or external providers.
• Lead training and self-inspection activities per local/global requirements.
• Ensure quality risk management processes and annual risk assessment reporting.
• Report quarterly Key Quality Indicators and address gaps to mitigate risk.
• Prepare annual/quarterly reviews and APQR/Training/Business Review materials.

Skills

GxP Knowledge

cGMP Knowledge

Quality Assurance

Regulatory Compliance

Project Management

Education

University degree in Pharmacy, Chemical Engineering, Chemistry, or related discipline

Tools

QMS

CAPA Process

Audit Management

Job description

Novartis Sağlık, Gıda ve Tarım Ürünleri San. Ve Tic. A.Ş.

Türkiye seeks a senior Quality professional to ensure GxP and local specifications are met, maintain documentation, and oversee quality systems. You will act as Qualified Person for Farmanova, perform batch release checks, and manage local regulatory interactions with health authorities. You will lead audits, CAPA, risk management, and annual quality planning across the country organization, driving continuous improvement and operational