Marketing Company Operation Country Quality Specialist

at  AstraZeneca

LOCATION: WARSAW, HYBRID WORK (3 DAYS FROM OFFICE, 2 DAYS FROM HOME)

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.
We are now looking for a Country Quality specialist that will be involved in the design and execution of a common quality management system (QMS) and strategy for GMP and GDP activities across the Commercial Marketing Company (MC) for the AZ product portfolio in country.
You will report into the CEEBA cluster lead and be part of the Global Quality Organisation.

• Provides leadership for GMP & GDP (Good Manufacturing and Good Distribution Practice) strategy and activities across market as the Quality partner to Commercial leader,
• Participates in defining the strategy for the commercial global markets ownership and execution of MCOQ GMP and GDP Quality System and framework in country.
• Define, develop, deploy and monitor the GMP/GDP policies and standards and execution in country market. Ensure documentation meets local regulatory standards and maintain oversight of documentation lifecycle management. Ensure MCOQ elements are captured in a business continuity plan.
• Accountable for a Country MC Quality Management Review process, preparation and execution and escalations to Operations, Commercial and R&D Sr. Leadership
• Represents Quality on cross-functional teams and steering committees related to MC market.
• Supports global standardisation, simplification and improvement of MCOQ Quality business processes. Supports the MC organisation that delivers against global processes, and aims to continuously improve in competence, compliance standards and innovative delivery of results.
• Plans, reviews and manages budget for the Country MCOQ Quality organisation.
• Accountable for local MCOQ Country specific activities related to, including but not limited to, resolution of Issue Management (post marketing surveillance e.g., Product quality and service and logistic, temperature excursion complaints, product security issues, local recall administrator, influence and decisions on local regulatory agency interactions, as applicable.
• Responsible for MCOQ GMP&GDP input into divestments/acquisitions/licensing agreements/product launches in country.
• Ensures change management process is followed.
• Ensures vendor management, from risk assessment, audits, QAA and qualification to ongoing oversight helping to resolve issues as applicable.
• Ensure quality risk management process is followed and active risk register maintained, as applicable.
• Ensures Customer qualification is performed.
• Responsible for country preparation for MCOQ related Regulatory Agency and AstraZeneca inspections/audits and responses.
• Implements an effective MCOQ self-assessment program.
• Responsible for ensuring QMS compliance and continuous improvement in the country and all issues are managed and closed on time, risks are identified and escalated to Global Quality. Responsible for the achievement of country KPIs and objectives/Quality Plans. Ensure country trends are addressed through development of country continuous improvement plans.
• 3rd Party management responsible for storage & distribution of samples to HCP
• Promotes a Quality Culture in the MC, ensures GDP/GMP/QMS training is performed and that Job descriptions as applicable reflect requirements
• Provides support to other MC in the CEEBA region.
• Ensures compliance with Safety Health and Environment and all other relevant regulations.