Senior Specialist Marketing Company Operations Quality Poland

Core 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. 

• Provides leadership for GMP & GDP (Good Manufacturing and Good Distribution Practice) strategy and activities across market and commercial SET area as the Quality partner to Commercial SET leader, Regional Commercial Head and Global Safety. 

• 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 markets. 

• Accountable for a Country MC Quality Management Review process, preparation and execution and escalations to Operations, Commercial and R&D Sr. Leadership and SET members. 

• Represents Quality on cross-functional and cross SET teams and steering committees related to MC market. 

• Drive global standardisation, simplification and 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, compliance standards and innovative delivery of results. 

• Provide training, supporting and coaching structure for regional Quality MCOQ network roles. 

• Participates in strategy and regional objectives setting for the MCOQ organisation. 

• Is the primary point of expertise for GMP & GDP activities impacting the 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, as well as common GxP process across the MC GxPs. 

• Accountable for Country specific regulatory requirements related to manufacture and distribution of AZ product in country, including but not limited to release of product atched, resolution of Issue Management, recalls, influence and decisions on local regulatory agency interactions, audits and inspection readiness and compliance to gain nd maintain AZ licence to operate. 

• Responsible for MCOQ GMP&GDP input into divestments/acquisitions/licensing agreements in country. 

• Demonstrated ability to work independently and in project settings to deliver objectives. 

• Keeps own knowledge of best practices, industry standards and new developments in quality management up to date. 

• Leads trouble shooting activities to resolve existing problems, make complicated judgements and anticipate future developments in AstraZeneca’s Quality related needs. 

• Responsible for managing Quality Standards and expectations across a broad range of services in order to provide a high quality, timely and cost-effective service. 

• Employs prepared information to discuss, plan and help carry out improvement plans, priority setting, investigation reports, quality or performance improvement recommendations. 

• Ensures adherence to Quality, Health and Safety, Good Manufacturing Practice, Good Laboratory Practice and regulatory requirements of own work and others work. 

• Responsible for ensuring that policies and standards meet regulatory requirements. 

• Ensures compliance with Good Manufacturing Practice, Safety Health and Environment and all other relevant regulations. 

• Carries out compliance reviews and reporting for external suppliers including issue resolution with senior Management and AZ site leaders, this may include, but is not limited to, the review and approval of investigation reports and participation in issue management teams. 

• Responsible for country preparation for Regulatory Agency and AstraZeneca inspections/audits and responses. 

• Supports local MC to deliver the license to operate, including but not limited to support for GMP&GDP audits and inspections, implementation effective self-assessment programs in the country of responsibility. 

• Responsible for ensuring QMS compliance and continuous improvement in the Region and all issues are Managed concerned and closed on time, risks are identified and escalated to Global Quality. 

• Promotes a Quality Culture in the MC sets strategy in the region and locally for execution of GMP/GDP excellence. 

• Responsible for the achievement of country KPIs and objectives/Quality Plans. Ensure country trends are addressed through development of country continuous improvement plans. 

• Adheres to Good Manufacturing Practice and Safety Health and Environment and ensures regulatory compliance 

• Contributes to development procedures in area of specialism and provides some technical input into the development of global standards for function and globally. 

• Proactively looks for opportunities to identify change and make efficiency savings, influence decisions and deliver the results whilst ensuring and appropriate level of compliance. 

• The jobholders are directly involved with/lead working groups, teams, and projects to proactively provide a global perspective and to drive consistency and standardization in all matters related to quality and GMP compliance. 

• 3rd Party management responsible for storage & distribution of samples to HCP. 

Education, Qualifications, Skills and Experience 

• Experience of Good Manufacturing Practice and Quality environment 

• Strong communication and influencing skills 

• Project and people management 

Desirable