Associate Director Marketing Company Operations Quality – MCOQ Poland Lead

Typical Accountabilities

For given country, develop, support and drive excellence in MCOQ GMP&GDP Quality activities to maintain the

local License to Operate.

Primary point of GMP&GDP contact for the country and maintains an effective governance structure to ensure

oversight of quality activities.

• Quality system leadership: Lead the application, maintenance, and continuous improvement of the Quality Management System for GMP/GDP activities within the country and across a complex Marketing Company environment, ensuring alignment with regulatory requirements, internal standards, global processes, and business objectives to maintain the local licence to operate.

• Country quality oversight: Serve as the primary GMP/GDP quality contact for the country, maintaining an effective governance structure to ensure oversight of local quality activities and consistent execution of the MCOQ GMP/GDP Quality System and framework.

• Strategy and execution: Provide leadership for the country GMP/GDP strategy and activities, contributing to regional and global MCOQ Quality strategy development and ensuring execution in alignment with AstraZeneca business priorities, including market expansion, product launches, and patient access.

• Policy and standards deployment: Define, develop, deploy, monitor, and continuously improve GMP/GDP policies, standards, and business processes in country markets, while driving simplification, standardisation, and efficiency.

• Compliance assurance: Provide expert leadership on GxP compliance, ensuring adherence to one set of GMP/GDP standards and common GxP processes across the Marketing Company, and Safety Health and Environment and assuring compliance with local regulatory requirements related to manufacture, distribution, and other applicable quality activities.

• Quality decision-making: Act as the country subject matter expert for GMP/GDP activities, providing expert advice and quality-focused decision-making on product quality, deviation management, change control, complaint handling, issue management, recalls, and other complex quality matters.

• Inspection and audit leadership: Plan, coordinate, and lead preparation for internal and external inspections and audits, including regulatory agency and AstraZeneca inspections, ensuring inspection readiness, effective response management, follow-up of actions, and implementation of sustainable improvement plans.

• Issue resolution and escalation: Lead complex investigations, troubleshooting, root cause analysis, and CAPA activities, ensuring timely resolution of quality issues, appropriate escalation to senior leadership and Global Quality, and robust closure of concerns and risks.

• Quality management review: Be accountable for the Country MC Quality Management Review process, including preparation, execution, performance reporting, and escalation of significant issues and risks to Operations, Commercial, R&D senior leadership, and relevant SET members.

• Performance monitoring: Monitor and analyse quality trends, KPIs, system effectiveness, and country performance metrics, using data and insights to support risk-based decisions, drive proactive issue resolution, and develop continuous improvement plans.

• Change and improvement leadership: Drive change management and continuous improvement initiatives across the quality area, proactively identifying opportunities for simplification, digital enablement, process optimisation, standardisation, and cost or efficiency gains while maintaining compliance and business continuity.

• Cross-functional leadership: Provide leadership through influence rather than direct line management, aligning stakeholders across quality, regulatory, manufacturing, supply chain, commercial, process development, global safety, and other relevant functions to deliver quality objectives.

• Representation and governance: Represent the quality function in local, regional, and global cross-functional forums, governance meetings, steering committees, projects, and working groups, ensuring quality risks, priorities, and requirements are understood and addressed.

• Capability building: Support development of a high-performing quality organisation by providing training, coaching, guidance, and informal leadership to country and regional MCOQ network roles, strengthening competence, compliance, and consistent application of quality expectations.

• Supplier and third-party oversight: Conduct compliance reviews and reporting for external suppliers and third parties, including issue resolution with senior management and AstraZeneca site leaders, and oversight of relevant third-party activities such as storage and distribution of samples to HCPs, where applicable.

• Regulatory interface: Support and influence interactions with local regulatory agencies, including inspection management, issue resolution, regulatory responses, and actions required to gain and maintain AstraZeneca’s licence to operate in country.

• Business support and transactions: Provide MCOQ GMP/GDP quality input into divestments, acquisitions, licensing agreements, and other strategic business activities within the country.

• Budget and operational planning: Plan, review, and manage the budget for the Country MCOQ Quality organisation, ensuring high-quality, timely, and cost-effective delivery of services and priorities.

• Quality culture and leadership expectations: Promote a strong Quality Culture across the Marketing Company by modelling compliance, continuous improvement, accountability, and practical problem-solving, and by leading without authority through expertise, collaboration, and credible communication across all levels of the organization.

• Professional expertise: Maintain up-to-date knowledge of industry best practices, regulatory expectations, and developments in quality management, contributing technical expertise to local procedures and, where relevant, to the development of global standards.

• CEEBA cluster leadership at the initiative level, aligning stakeholders, prioritizing strategic initiatives, and driving execution to deliver business objectives.

Requirements:

Essential

• Masters' degree, in science / engineering field such as Pharmacy, Biology, or Chemistry;

• At least 5 years of prior experience in GxP within a pharmaceutical and compliance management environment;

• Experience working cross-functionally across the supply chain with groups such as regulatory, manufacturing, supply and capability, and account management;

• Experience working with digital tools and applications related to quality monitoring, reporting, documentation, and analysis

•  Strong communication and influencing skills

Desirable

• Experience working cross-functionally to influence a complex organizational environment, preferred; Multi-national and cross-cultural experience preferred

•  Understanding of multiple aspects of physical plant, technical equipment and other elements of facilities management

• Meet national requirements and approved to be an eligible QP / RP;

• Experience working with digital tools and applications related to quality monitoring, reporting, documentation, and analysis

• Project and people management

Date Posted

Closing 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.