Job Description
AstraZeneca is one of the world’s leading biopharmaceutical companies, delivering innovative medicines for diseases that pose major challenges to modern healthcare. Our strength comes from the diversity of our people—their experiences, passion, and potential—fueling meaningful progress every day. We act with shared values and the highest ethical standards, combining science, responsibility, and ambition.
If you want to make a real impact for patients and grow in an environment that values diversity and collaboration, join us as Senior Specialist Marketing Company Operations Quality Poland r esponsible party for overseeing the design,implementationand delivery of a common Quality system and strategy for GMP and GDP activities across in Commercial marketing company forall ofthe AZ productportfolio in country. Participates in development of Global AZ MCOQ Quality Strategy and executes countrystrategy for MCOQ Quality and Marketing Company GMP/GDP aligned with AZ’s bold ambition strategy for market expansion, productlaunchesand accessibility. Accountable for assurance of compliance with worldwidestandards for all local GMP & GDP activities and connects the MC offices the broader Operations Quality and R&D organisationoperatingunder One AZ QMS.
For given country, develop, support and drive excellence in MCOQ GMP&GDP Quality activities tomaintainthe local License to Operate. Primary point of GMP&GDP contact for the country andmaintainsan effective governance structure to ensure oversight of quality activities.
- Provides leadership for GMP & GDP (Good Manufacturing and Good Distribution Practice) strategy andactivities across market and commercial SET area as the Quality partner to Commercial SET leader, RegionalCommercial Head and Global Safety
- Participates in defining the strategy for the commercial globalmarketsownership and execution of MCOQGMP and GDP Quality System and framework in country
- Define, develop,deployandmonitorthe GMP/GDP policies and standards and execution in country markets
- Accountable for a Country MC Quality Management Review process,preparationand execution andescalations to Operations, Commercial and R&D Sr. Leadership and SET members
- RepresentsQuality on cross-functional and cross SET teams and steering committees related to MC market
- Drive global standardisation,simplificationand improvement of MCOQ Quality business processes.
- Develops and sustains a high-quality organisation that delivers against global processes, and aims to continuously improve in competence, compliancestandardsand innovative delivery of results.
- Provide training, supporting and coaching structure for regional Quality MCOQ network roles
- Participates in strategy and regionalobjectivessetting for the MCOQ organisation
- Is the primary point ofexpertisefor GMP & GDP activitiesimpactingthe MCOQ organisation in country
- Plans, reviews and manages budget for the Country MCOQ Quality organisation
- Accountable for compliance assurance and working to one set of GMP & GDP standards and processes, aswell as commonGxPprocess across the MCGxPs
- Accountable for Country specific regulatory requirements related to manufacture and distribution of AZproduct in country, including but not limited to release of product atched, resolution of IssueManagement,recalls,influence and decisions on local regulatory agency interactions, audits and inspectionreadiness and compliance to gain ndmaintainAZ licence tooperate
- Responsible for MCOQ GMP&GDP input into divestments/acquisitions/licensing agreements in country
- Demonstrated ability to work independently and in project settings to deliverobjectives
- Keeps own knowledge of best practices, industrystandardsand new developments in quality managementup to date
- Leads trouble shooting activities to resolve existing problems, make complicated judgements and anticipatefuture developments in AstraZeneca’s Quality related needs
- Responsible for managing Quality Standards and expectations across a broad range of servicesin order toprovide a high quality,timelyand cost-effective service
- Employs prepared information to discuss, plan and help carry out improvement plans, priority setting,investigation reports,qualityor performance improvement recommendations
- Ensures adherence to Quality, Health and Safety, Good Manufacturing Practice, Good Laboratory Practiceand regulatory requirements of own work and others work
- Responsible for ensuring that policies and standards meet regulatory requirements
- Ensures compliance with Good Manufacturing Practice, SafetyHealthand Environment and all otherrelevant regulations
- Carries out compliance reviews and reporting for external suppliers including issue resolution with senior Managementand AZ site leaders, this may include, but is not limited to, the review and approval of investigation reportsandparticipation in issue management teams
- Responsible for country preparation for Regulatory Agency and AstraZeneca inspections/audits andresponses
- Supports local MC to deliver the license tooperate, including but not limited to support for GMP&GDPaudits and inspections, implementation effectiveself-assessmentprograms in the country of responsibility.
- Responsible for ensuring QMS compliance and continuous improvement in the Region and all issues areManagedconcerned and closed on time, risks areidentifiedand escalated to Global Quality.
- Promotes a Quality Culture in the MC sets strategy in the region and locally for execution of GMP/GDPexcellence.
- Responsible for the achievement of country KPIs and objectives/Quality Plans. Ensure country trends areaddressed through development of country continuous improvement plans.
- Adheres to Good Manufacturing Practice and Safety Health and Environment and ensures regulatorycompliance
- Contributes to development procedures in area of specialism and provides some technical input into thedevelopment of global standards for function and globally
- Proactively looks for opportunities toidentifychange and make efficiency savings, influence decisions anddeliver the results whilst ensuring andappropriate levelof compliance
- The jobholders are directly involved with/lead working groups, teams, and projects to proactively provideaglobal perspective and to drive consistency and standardization in all matters related to quality and GMPcompliance
- 3rd Party management responsible for storage & distribution of samples to HCP
Education, Qualifications,Skillsand Experience
University degree in pharmacy, life sciences or related field.
Experience in Bio/pharmaceutical industry within Quality.
Experience in/or GDP, GMP , QMS management
Demonstrated ability to work independently and in project settings to deliver objectives.
Able to lead trouble shooting activities to resolve existing problems, make complicated judgements and anticipate future developments.
Strong communication and influencing skills.
Project and people management.
Polish language is a must!
Join AstraZeneca and help us deliver life-changing medicines. Be among our employees who continue to make us an innovation-driven company that stands firmly among the world’s leaders in biopharmaceuticals. APPLY!
Date Posted
09-cze-2026
Closing Date
04-lip-2026
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.
