Manager, Quality Data Steward

at  Alexion PharmaceuticalsInc

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.

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 GxP 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.
  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.