QA Compliance Specialist

About the role

Novartis is hiring a QA Compliance Specialist in Târgu Mureș, Romania (hybrid, Level 3). The role supports and strengthens GxP compliance, audit readiness and quality management so that business operations, systems, site activities and products comply with the Novartis Quality Manual, internal policies, cGxP requirements, data integrity standards and applicable local and international regulations. Relocation support is not offered.

Key responsibilities

• Own and execute quality assurance activities ensuring compliance with GMP, GxP, the Novartis Quality Manual, internal procedures, HSE standards and regulatory expectations.
• Monitor quality-related activities such as systems, utilities, alarms, environmental monitoring trends, equipment status, deviations and non-conformities.
• Take part in internal and external audits and inspections, support the quality system, respond to findings and escalate quality or compliance risks.
• Review, verify and approve documentation for qualification, calibration, preventive maintenance, validation, transport validation, storage qualification, equipment inventories and annual planning for production, laboratory, technical, utility and IT systems.
• Ensure compliance and validation of GxP-impacting computerized systems, including validation deliverables, SOPs, security, backup, archival, change control, incident management, audit trails and user access.
• Support the documentation system by reviewing procedures for operation, sanitation, maintenance, calibration, qualification and validation, and assign identification numbers to equipment and IT systems.
• Contribute to quality reporting, product quality reviews, deviation investigations, annual product analysis, GMP training and performance management.
• Lead and support Operational Excellence and Continuous Improvement initiatives using Lean Manufacturing and Six Sigma, including cost reduction, KPI monitoring, root cause investigation and visual management.

Required profile

• Degree in a pharmaceutical or related scientific field (Pharmacy, Chemistry, Chemical Engineering, Medicine, Biology).
• 3+ years of experience in the pharmaceutical industry, preferably in quality, GMP, validation or compliance.
• Strong knowledge of pharmaceutical quality requirements, international GMP standards and regulatory expectations.
• Good English, able to understand and communicate professional and technical information.

Required skills

• Solid understanding of quality assurance principles, GMP and compliance processes.
• Proficiency in MS Office and standard IT applications used for quality, documentation, reporting and compliance.
• Collaboration, data integrity, leadership and continuous improvement mindset.

What we offer

• Expected annual base salary of RON 84,560 to 157,040, with a possible performance-based bonus.
• Insurance plans, retirement plans, wellbeing resources and global recognition programs.
• Flexible and hybrid working options where possible, and at least 14 weeks of paid parental leave.