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ABOUT ASTRAZENECA
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.
ROLE SUMMARY
Is the responsible party for overseeing the design, implementation and delivery of a common Quality system and strategy for GMP and GDP activities across in Commercial marketing company for all of the AZ product portfolio in GCC.
Participates in development of Global AZ Affiliate Quality Strategy and executes country strategy for Affiliate Quality and Marketing Company GMP/GDP aligned with AZ’s 2030 bold ambition strategy for market expansion, product launches and accessibility.
Accountable for assurance of compliance with worldwide standards for all local GMP & GDP activities and connects the affiliate offices the broader Operations Quality and R&D organisation operating under One AZ QMS.
What you’ll do
For GCC, develop, support and drive excellence in Affiliate GMP&GDP Quality activities to maintain the local License to Operate.
Primary point of GMP&GDP contact for the GCC 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 Affiliate GMP and GDP Quality System and framework in GCC.
Define, develop, deploy and monitor the GMP/GDP policies and standards and execution in GCC markets.
Accountable for a GCC Affiliate 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 Affiliate GCC markets.
Drive global standardisation, simplification and improvement of Affiliate 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 Affiliate network roles.
Participates in strategy and regional objectives setting for the GCC MC Affiliate Quality organisation.
Is the primary point of expertise for GMP & GDP activities impacting the affiliate organisation in the GCC markets.
Plans, reviews and manages budget for the GCC Affiliate 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 GCC Affiliate GxPs.
Accountable for GCC Country specific regulatory requirements related to manufacture and distribution of AZ product in country, including but not limited to release of product batched, resolution of Issue Management, recalls, influence and decisions on local regulatory agency interactions, audits and inspection readiness and compliance to gain and maintain AZ licence to operate.
Responsible for Affiliate GMP&GDP input into divestments/acquisitions/licensing agreements in GCC MC.
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 GCC country preparation for Regulatory Agency and AstraZeneca inspections/audits and responses.
Supports local GCC 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 GCC Cluster and all issues are managed and closed on time, risks are identified and escalated to Global Quality.
Promotes a Quality Culture in the Affiliate sets strategy in the region and locally for execution of GMP/GDP excellence.
Responsible for the achievement of GCC MC 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.
*Registered Pharmacist is a requirement for this open position in order to meet the GCC requirements.
Essential for the role
Degree level or equivalent
Experience of Good Manufacturing Practice and Quality environment
Strong communication and influencing skills
Project and people management
Desirable for the role
Understanding of multiple aspects of physical plant, technical equipment, and other elements of facilities management.
Why AstraZeneca?
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.
So, what’s next?
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.
Where can I find out more?
Our Social Media, Follow AstraZeneca on LinkedIn
Follow AstraZeneca on Facebook
Follow AstraZeneca on Instagram
Date Posted
01-أكتوبر-2023
Closing Date
10-أكتوبر-2023
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.
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