Position Summary The 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 & ResponsibilitiesData GovernanceDefine 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 rulesMetrics implementationSupport 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 requirementsSME 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 mattersProvide effective oversight and escalation of data quality and data integrity issues to mitigate potential risks and support regulatory and industry requirementsEnable 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 OfficeEnsuring compliance to computer system validation and system development lifecycle requirements.Operational ExcellencePartner 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 enablementSupport digital enablement strategy in alignment with Quality Center of Excellence pipelineEnables 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 QualificationsBachelors 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 providersAbility to navigate, problem-solve, execute and lead in a dynamic, fast paced and evolving environmentLean or Six Sigma Certification preferred5+ years of experience post degree in a pharma/biotech environment2+ years of experience working in a Quality roleThorough understanding of GxP regulations and their applicationProven track record of planning and managing complex projects with aggressive timelinesStrong verbal and written communication skills including tailored communications to senior leadersExperience 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.Date Posted20-Sep-2024Closing Date03-Oct-2024Our mission is to build an inclusive and equitable environment.
We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process.
We welcome and consider applications from all qualified candidates, regardless of characteristics.
We offer reasonable adjustments/accommodations to help all candidates to perform at their best.
If you have a need for any adjustments/accommodations, please complete the section in the application form.
