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Associate Director, Data Governance & CSV Technology

Jubilant HollisterStier Spokane

This is a Full-time position in Spokane, WA posted November 20, 2021.

Jubilant HollisterStier, LLC is currently recruiting for an Associate Director, Data Governance & CSV Technology to join our team in Spokane, Washington! In this role, you will be responsible for the overall management and execution of activities/system compliance and data governance. This role manages relationships with external (US regulatory bodies, auditors, etc.) and internal stakeholders (IS, Quality, Operations, Supply Chain, Commercial, etc.) to define and implement data governance policies and practices.

ABOUT OUR BENEFITS:

We provide a culture that values opportunity for professional growth and development. We offer roles that are challenging and rewarding. Our benefits include highly competitive base salary; comprehensive medical, dental, vision, and disability benefits; company matched retirement savings program; health and wellness programs; as well as a generous paid time off program. We desire individuals who seek a workplace that value individuality and authentic self in order to achieve our organization’s mission.

ABOUT THE JOB:

  • Manage site level IT system and applications including data backup and archival (Compliance of Applications & System; IT & Quality)
  • Manage administrative rights and user management for the site level applications
  • Facilitate and conduct periodic reassessment of as part of validation life cycle re-qualifications/re-assessments
  • SME for sites in managing IT system compliance related issues and leading the efforts related to compliance in these areas
  • Present and defend Jubilant policies, procedures and practices as the SME during client and regulatory investigations
  • Prepare site level master computer system validation
  • Define policies and procedures for FDA 21CFR part 11, Canadian Regulation including GUI-001 and data governance and data integrity requirements, EU Regulations including Annex 11, GAMP5, PIC/S Guidance and FDA Guidance for Industry
  • Lead CFT (application owner, QA and engineering) conducting SLRA, FLRA and 21CFR part 11 risk assessments
  • Support deviation Investigations related to site level IT system and applications
  • Execute change management effectively across cross-functional teams
  • Synthesize inputs from various stakeholders into coherent deliverables and outputs
  • Align various stakeholders and drive teams toward a common goal

ABOUT THE IDEAL CANDIDATE:

Qualifications:

  • Bachelor’s degree in Information Technology, Computer Science or related discipline with Quality Systems experience working in an FDA regulated industry: Pharmaceutical Contract Manufacturing; Master degree in Information Technology preferred but not required
  • 10+ years of relevant experience in the following fields: data usage, process analysis, process improvement, technology development/support with solid understanding of data governance, standards and practices in handling large datasets from numerous sources
  • Experience in providing and managing data solutions across Operations, Quality, Commercial, Supply Chain and Clinical data domains in the Pharmaceutical Industry
  • Experience as a SME within a Quality Compliance role with specific responsibility in Data Governance and Computer System Validation
  • Ability to collaborate at all levels of an organization with demonstrated capability to achieve goals in a fast-paced dynamic cooperative environment
  • Experience working in a matrix and decentralized environment

You must be authorized to work for Jubilant in the United States without VISA sponsorship.

Jubilant HollisterStier, LLC, a well-established member of the business community in Spokane, Washington, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. Jubilant HollisterStier is also a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. Jubilant HollisterStier is a proud member of the Jubilant Pharma family. For more information, visit http://www.jublhs.com/

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