Senior Quality Leader - GxP, Compliance & Qualified Person

Novartis; Ataşehir; On-site; TRY 350,000 - 700,000; Full time

Job summary

Novartis Türkiye seeks a Quality Operations professional to own and develop local QMS, ensuring GxP compliance and alignment with Novartis policies. You will lead CAPA, audits, vendor management, and regulatory interactions across the Country Quality organization.

You will drive continuous improvement, guide changes affecting product quality, and oversee recalls, MAH reviews, and annual quality planning with cross-functional teams.

Qualifications

• University degree in a scientific field relevant to QA/QA-Audit roles.
• Advanced knowledge of GxP, GMP, GDP and regulatory requirements.
• Experience with CAPA processes, QMS, and quality risk management.
• Strong communication skills and ability to collaborate across functions.
• Experience with audits, change control, and deviation investigations.
• Ability to lead senior stakeholders and drive compliance initiatives.

Responsibilities

• Manage implementation and maintenance of a local QMS compliant with regulatory requirements and Novartis policies.
• Ensure timely updates to local guidelines including GMP, GDP, barcode requirements.
• Fulfil duties of Qualified Person for Farmanova including batch releases.
• Perform release activities for supporting clinical products.
• Approve artwork changes for Farmanova products.
• Collaborate with country functions to ensure effective Country Quality System operations.
• Maintain communication with local Health Authorities and track commitments.
• Manage recalls in compliance with local regulations and Novartis policies.
• Participate in investigation of quality deviations and CAPA actions.
• Lead escalation processes and track required actions to closure.
• Review and approve SOPs and changes affecting product quality.
• Lead MAH reviews of APQRs, and oversee annual APQR planning and trend evaluation.
• Ensure annual Quality Plan is prepared and executed.
• 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 practices and annual risk assessments.
• Report quarterly Key Quality Indicators and address gaps to mitigate risk.
• Prepare annual/quarterly review reports and related materials.
• Oversee third-party warehouse quality and collaborate with partners.
• Lead vendor management, supplier qualification, and QA agreements.

Skills

Proactive mindset

Resilience

Business acumen

Curiosity

Sound judgement

Project management

Education

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

Job description

Novartis Türkiye seeks a Quality Operations professional to own and develop local QMS, ensuring GxP compliance and alignment with Novartis policies. You will lead CAPA, audits, vendor management, and regulatory interactions across the Country Quality organization.

You will drive continuous improvement, guide changes affecting product quality, and oversee recalls, MAH reviews, and annual quality planning with cross-functional teams.