Ireland Job Openings
Alexion Pharmaceuticals,Inc.
Manager, Quality Data Steward
Dublin
September 20, 2024
Location: Dublin, Ireland
Job reference: R-209327
Date posted: 09/20/2024
Position Summary
The Manager,Quality Data Steward is a role requiring a high-energy professional with exceptional organizational, planning and project management skills. The ideal candidate should thrive in a fast-paced environment and possess enthusiastic interest in adding value to the Central Quality Systems and Compliance (CQSC) organization and the company on a daily basis. Successful candidates will be proactive, self-motivated and relationship-oriented, with a proven ability to multi-task, a strong quality and compliance mindset and appropriately prioritize work effectively.
The role is responsible for the maintence and support of an Alexion Quality Data Governance model and quality data products as it relates to digital enablement of Quality systems and tools. This individual will provide strategic and tactical support to various quality teams, especially our Quality Digital Enablement team and Quality Data Reporting team and other teams throughout the Rare Disease Unit by maintaining a data governance structure, ensuring compliance to computer system validation regulations, supporting internal processes and technologies that support our goal to deliver high quality FAIR (Findable, Accessible, Interoperable, Reusable) data resulting in efficient, reliable business intelligence. This individual will work within the Quality Center of Operational Excellence and assist in providing tools and guidance to various stakeholders as part of a broader strategic vision for the team.
Job Duties & Responsibilities
Data Governance
Essential Qualifications
Astra Zeneca 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.
The Manager,Quality Data Steward is a role requiring a high-energy professional with exceptional organizational, planning and project management skills. The ideal candidate should thrive in a fast-paced environment and possess enthusiastic interest in adding value to the Central Quality Systems and Compliance (CQSC) organization and the company on a daily basis. Successful candidates will be proactive, self-motivated and relationship-oriented, with a proven ability to multi-task, a strong quality and compliance mindset and appropriately prioritize work effectively.
The role is responsible for the maintence and support of an Alexion Quality Data Governance model and quality data products as it relates to digital enablement of Quality systems and tools. This individual will provide strategic and tactical support to various quality teams, especially our Quality Digital Enablement team and Quality Data Reporting team and other teams throughout the Rare Disease Unit by maintaining a data governance structure, ensuring compliance to computer system validation regulations, supporting internal processes and technologies that support our goal to deliver high quality FAIR (Findable, Accessible, Interoperable, Reusable) data resulting in efficient, reliable business intelligence. This individual will work within the Quality Center of Operational Excellence and assist in providing tools and guidance to various stakeholders as part of a broader strategic vision for the team.
Job Duties & Responsibilities
Data Governance
- Define the scope of the Data and identification of critical data elements/data assets.
- Create processes and procedures in alignment with quality and compliance regulations and in support of Alexion’s QMS.
- Development and prioritization of data initiatives & strategies to meet business goals.
-
Manage:
- Data Quality rules
- Metrics implementation
- Support the development and adoption of master and reference data consumption.
- Data lifecycle requirements.
- Metadata and business glossary requirements as applicable.
- Partner with key business stakeholders to design and implement a enterprise data governance operational model that aligns process, systems and technologies to fully harness our data while adhering to relevant regulatory requirements
- SME of data governance within the Central Quality team. Partners with stakeholders both internal and external to the Central Quality team to ensure that the proper data structures and level of specificity are captured throughout our environment.
- Serve as internal expert for all data governance matters
- Provide effective oversight and escalation of data quality and data integrity issues to mitigate potential risks and support regulatory and industry requirements
- Enable continuous improvement of data management practices to ensure data assets are FAIR (Findable, Accessible, Interoperable and Reusable).
- Build and lead training on enterprise governance and data management to ensure a continuous culture of compliance across the organization.
- Manages permanent or contingent workers, on an as needed basis, to support the Quality Data Governance Office
- Ensuring compliance to computer system validation and system development lifecycle requirements.
- Partner with Associate Director of Quality Center of Excellence to implement the strategic vision of the department, especially in regards to data governance methodology and digital enablement
- Support digital enablement strategy in alignment with Quality Center of Excellence pipeline
- Enables strong team performance by understanding all facets of Quality and works with stakeholders to investigate and diagnose operational issues; partners across the organization to identify solutions which increase efficiency and improve performance and drive data metrics and reportability.
- Champions a quality-mindset and inclusive culture
Essential Qualifications
- Bachelors degree in science, engineering, business or data governance. Masters degree preferred.
- 5+ years of relevant data governance/management experience within the Pharmaceutical, Biotechnology or Medical Device Industry.
- Perferred experience in Data Office formation, Governance implementation and System Development Lifecycle processes.
- Excellent influencing skills, with demonstrated ability to work collaboratively and effectively with key business partners, IT and external service providers
- Ability to navigate, problem-solve, execute and lead in a dynamic, fast paced and evolving environment
- Lean or Six Sigma Certification preferred
- 5+ years of experience post degree in a pharma/biotech environment
- 2+ years of experience working in a Quality role
- Thorough understanding of Gx P regulations and their application
- Proven track record of planning and managing complex projects with aggressive timelines
- Strong verbal and written communication skills including tailored communications to senior leaders
- Experience in Data Office formation, Governance implementation and System Development Lifecycle processes would be preferred.
- Travel may be required, however advanced notice would be provided in all cases.
Astra Zeneca 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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