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Tijana Kesar

@tijanakesar1

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Senior Quality Assurance leader with 15+ years in pharma QA/RA.

Serbia

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What I'm looking for

I’m seeking a senior QA/RA role in pharma where I can lead QMS deployment, ensure GMP/GDP compliance, manage regulatory readiness, and mentor cross-functional teams in a collaborative, quality-driven environment.

I am a senior Quality Assurance professional with over 15 years' experience in pharmaceutical quality and regulatory affairs, focused on ensuring GMP/GDP compliance and operational deployment of local quality systems. I have led commercial quality activities, managed batch and market release, hosted regulatory inspections, and driven CAPA, deviations, change control, supplier qualification and training programs.

My background includes roles as Commercial Quality Manager, Qualified Person for batch release, deputy head of QA, and pharmacovigilance coordinator, and I bring strong leadership, decision-making and problem-solving skills paired with hands-on experience in QMS tools such as SAP ECC, TrackWise and Veeva Vault Quality. I deliver consistent inspection readiness and practical alignment of local quality practices with corporate and regional standards.

Experience

Work history, roles, and key accomplishments

Current

Senior Manager Commercial Quality

Current

Teva

Jun 2018 - Present (7 years 4 months)

Lead commercial quality for RS & MNE, deploying local QMS and ensuring GMP/GDP compliance to enable efficient product distribution and regulatory inspection readiness. Managed change control, deviations, CAPAs, complaints, recalls and quality agreements to maintain supply continuity.

GDP Quality Management Change Control CAPA

Qualified Person (QP) for Batch Release

Hemofarm

Aug 2016 - Jun 2018 (1 year 10 months)

Served as Qualified Person responsible for batch and market release and oversight of QA/RA processes to ensure compliant product release. Coordinated GMP/GDP training and maintained batch release documentation.

Batch Qualified GMP Documentation GDP QA Processes Training Documentation Regulatory Compliance

Deputy Head of Quality Assurance

Ivančić i Sinovi

Feb 2013 - Aug 2016 (3 years 6 months)

Supported the Head of QA in driving regulatory audit readiness, managing QMS activities and maintaining compliance across QA operations. Oversaw supplier qualification and corrective actions to improve quality performance.

CAPA Deviations & Compliance

Pharmacovigilance Coordinator

Ivančić i Sinovi

Oct 2008 - Feb 2013 (4 years 4 months)

Coordinated pharmacovigilance and regulatory affairs activities, supporting safety reporting and compliance with regulatory requirements. Contributed to maintaining GMP/GDP standards and regulatory documentation.