Marketing Company Operations Quality Country Specialist
AstraZeneca
Grad Zagreb, Unknown, Hrvatska
Contract
Competitive
OfficeSenior
Marketing Company Operations Quality Country Specialist
Location: Zagreb, Croatia
Contract Type: Fixed-term maternity cover role for 1 year
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company focused on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases.
We are now looking for a Marketing Company Operations Quality Country Specialist to support the design, implementation and continuous improvement of the Quality Management System (QMS) and quality strategy for GMP and GDP activities across the local market for AstraZeneca’s product portfolio in Croatia.
This is a fixed-term maternity cover role for 1 year, based in Zagreb, Croatia.
In this role, you will report to the CEEBA Cluster Lead and be part of the Global Quality Organisation, acting as a key quality partner to the commercial business and helping to ensure compliance, quality oversight and continuous improvement across country operations.
Quality partnership: Act as the Quality partner to the Commercial organisation, supporting GMP and GDP strategy and activities across the market.
Quality systems: Support the implementation and execution of the MCOQ GMP and GDP Quality System and framework in country.
Policies and standards: Define, develop, deploy and monitor GMP/GDP policies, standards and execution in the local market.
Documentation management: Ensure documentation meets local regulatory requirements and maintain oversight of documentation lifecycle management.
Business continuity: Ensure relevant MCOQ elements are included in the country business continuity plan.
Management review: Be accountable for the preparation and execution of the Country Marketing Company Quality Management Review process and escalation of key topics to senior stakeholders.
Cross-functional collaboration: Represent Quality on cross-functional teams and steering committees related to the local market.
Continuous improvement: Support global standardisation, simplification and continuous improvement of MCOQ Quality business processes.
Budget management: Plan, review and manage the budget for the country MCOQ Quality organisation.
Issue management: Manage country-specific quality activities, including post-marketing surveillance topics such as product quality complaints, service and logistics issues, temperature excursions, product security issues, and local recall administration.
Regulatory interactions: Support and influence interactions with local regulatory authorities, where applicable.
Business change support: Provide MCOQ GMP/GDP input into divestments, acquisitions, licensing agreements and product launches in country.
Change management: Ensure the local change management process is followed effectively.
Vendor management: Oversee vendor management activities, including risk assessments, audits, quality agreements, qualification and ongoing oversight.
Risk management: Ensure the quality risk management process is followed and that an active risk register is maintained where applicable.
Customer qualification: Ensure customer qualification activities are completed as required.
Inspection and audit readiness: Prepare the country for MCOQ-related regulatory inspections and AstraZeneca audits, including responses and follow-up actions.
Self-assessment: Implement and maintain an effective MCOQ self-assessment programme.
Compliance and KPIs: Ensure QMS compliance, timely closure of quality issues, appropriate risk escalation, and delivery of country KPIs, objectives and quality plans.
Trend management: Ensure country quality trends are reviewed and addressed through continuous improvement plans.
Third-party oversight: Manage relevant third-party activities related to the storage and distribution of samples to healthcare professionals.
Quality culture and training: Promote a strong Quality Culture within the Marketing Company and ensure GDP/GMP/QMS training is completed and reflected in relevant job descriptions.
Regional support: Provide support to other Marketing Companies within the CEEBA region, as needed.
Regulatory compliance: Ensure compliance with Safety, Health and Environment requirements and all other relevant regulations.
Education: University degree in pharmacy, life sciences or a related field.
Industry experience: Experience in the bio/pharmaceutical industry within a Quality function.
Technical knowledge: Experience in and/or knowledge of GDP, GMP and QMS management.
Language skills: Native-level Croatian language skills are required. Strong English communication skills are also expected for collaboration within the regional and global organisation.
Independent working: Demonstrated ability to work independently and within project settings to deliver objectives.
Problem solving: Ability to lead troubleshooting activities, resolve existing problems, make complex judgements and anticipate future developments.
Communication: Strong communication and influencing skills.
Project management: Experience in project management and coordinating stakeholders effectively.
People leadership: People management or leadership capability would be an advantage.
Why AstraZeneca
At AstraZeneca, we are dedicated to being a Great Place to Work, where people are empowered to push the boundaries of science and unleash their entrepreneurial spirit. We offer an inclusive culture that values diversity, collaboration, learning, growth and development. This is an opportunity to make a meaningful difference to medicine, patients and society while being part of an exciting journey to pioneer the future of healthcare.
Please apply by submitting your CV via our global careers website.
Date Posted
17-Juni-2026Closing Date
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.