Country Quality Manager

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About the role

Salary Range: Kč906,500.00 - Kč1,683,500.00   Job Description Summary #LI-Hybrid Location: Prague, Czechia This role is based in Prague, Czechia. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. The Country Quality Manager is responsible for the product quality conformity with specifications and that production activity is compliant with Novartis quality policy and GxP requirements. This role will ensure that relevant documentation is up-to-date and archived correctly and “state of the art” GxP know-how and future trends in the field of GxP.   Job Description We offer a fixed-term contract until 31st of March 2028. Major Accountabilities: • Ensure handling, manufacturing, and distribution of biopharmaceutical and pharmaceutical products comply with the Novartis Quality Manual, effective Quality Agreements, relevant GxP regulatory requirements, and local SOPs. • Review batch documentation for accuracy and completeness, safely archive original records for the required period, and plan, conduct, and monitor self-inspection programs across all sections. • Conduct GxP monitoring, manage QA investigations for noncompliance, follow up on corrective actions, and ensure proper documentation and archiving of related quality records. • Manage and approve critical quality issues, including deviations, complaints, recalls, counterfeits, product tampering, and stability failures, ensuring investigations and required actions are completed correctly and on time. • Escalate quality or instability issues according to Novartis escalation policies, initiate required market actions, support Global Quality Assessments, and manage change requests from receipt through implementation and closure. • Assess quality trends, drive continuous improvement, maintain awareness of updated GxP and regulatory requirements, identify areas requiring SOPs, and initiate SOP development where needed. • Plan, implement, and monitor regular GxP training programs for employees, including responsibility for the annual training program. • Maintain cross-functional communication with internal teams, authorities, local partners, stakeholders, and Global QA; support product launches and market release activities; and report technical complaints, adverse events, or special case scenarios related to Novartis products within 24 hours. Obligatory Requirements: • University degree in Pharmacy, Life Sciences, Chemistry, or a related discipline. • Minimum 3 years of Quality Assurance experience within the pharmaceutical industry. • Solid knowledge of GMP and GDP requirements. • Experience collaborating across functions and boundaries, with functional breadth in operations management and execution. • Experience with deviation management, CAPA, change control, complaints, and quality risk management; experience as a Qualified Person (QP) or supporting QP activities is an advantage. • Strong competencies in resilience, operational excellence, project excellence, flexibility, and effective communication with business stakeholders, warehouse providers, and global functions. • Technical knowledge of product release, quality assurance, quality change control, quality management, regulations and guidelines, and risk management. • Fluent Czech and/or Slovak, with professional English proficiency. Benefits & Rewards At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen. • Expected Annual Base Salary Range for role:   906,500.00 to 1,683,500.00 CZK Annual The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Nova

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