Computer Science: Information Systems, Computer Science: Information Technology
4 Year Degree
Partner with the Quality group to provide support in managing both ongoing and future projects and initiatives, including but not be limited to: Veeva Vault Quality/QMS and ComplianceWire. Responsibilities include the following:
Partner closely with Quality business stakeholders/users to elicit and understand their business processes and in turn analyze, document and translate them into requirements and drive the identification and selection of appropriate software vendors and solutions.
Manage initiative/project portfolio and meet regularly with Business Sponsor/Owner to review initiatives and their respective budget/timeline/resources for prioritization.
Work with stakeholders to identify and engage potential vendors, drive the vendor selection process, and oversee the negotiation of contracts and statements of work.
Implement projects in accordance with the IT System Development Lifecycle (SDLC).
Develop project plans to allocate and manage the necessary resources for the successful implementation of appropriate solutions. Apply project management skills and employ the necessary tools to track project tasks and deliverables. Provide post-implementation support as required.
Provide administration support of various solutions or platforms, including but not limited to EDMS, QMS, and compliance-related solutions.
Work in concert with the business owners/business admins to actively manage and optimize solutions through their lifecycle, including changes, upgrades, and enhancements.
Must have Bachelor’s degree in Information Technology or related field and 5 years of experience in drug development with at least 3 years project management experience in the biopharmaceutical industry. Experience must include the following: Quality Assurance and Quality Compliance in a drug development environment; working on quality applications and change management activities for GxP applications and systems; working within the framework of a validated project lifecycle; working with Quality-related solutions and systems, including document management systems and quality systems (deviations, change control); and gathering requirements from Business users to create use case and functional requirement documents.
Internal Number: bbb-SBSA
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