Country Quality Manager

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 Novartis will be reviewed periodically.

In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.

The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave. You may be eligible for a company vehicle or a car allowance in accordance with the applicable local Novartis policies and guidelines.

Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.

Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf

Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.

Monthly pension contribution matching your individual contribution up to 3% of your gross monthly base salary; Risk Life Insurance (full cost covered by Novartis); 5-week holiday per year; (1 week above the Labour Law requirement) ; 4 paid sick days within one calendar year in case of absence due to sickness without a medical sickness report; Cafeteria employee benefit program – choice of benefits from Benefit Plus Cafeteria in the amount of 17,500 CZK per year; Meal vouchers in amount of 105 CZK for each working day (full tax covered by company); Public Transportation allowance; MultiSport Card, Employee Share Purchase Plan; Find out more about Novartis Business Services: https://www.novartis.cz/

 

Skills Desired

Analytical Thinking, Audit Inspections, Business Awareness, Change Adoption, Communication, Data Integrity, Data Literacy, GMP Compliance, Managing Ambiguity, Operational Excellence, Problem Solving, Process Optimization, Product Distribution, Quality Assurance (QA), Quality Management Systems (QMS), Regulatory Compliance, Risk-Based Decision Making, Stakeholder Management, Storytelling, Supply Chain Quality