Senior Business Systems Analyst, Quality
Join bluebird bio's enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. We are seeking an outstanding Business Systems Analyst or Senior Business Systems Analyst to support our Quality group. Reporting to the Director of IT R&D, the primary function of this role will be to partner with the Quality group Business Owners to provide support in managing both ongoing and future projects and initiatives. This will initially include but not be limited to: Veeva Vault Quality/QMS and ComplianceWire. We are interested in self-motivated candidates requiring little supervision, that embrace learning within challenging circumstances, and who will thrive in a fast-paced, dynamic environment.
About the role:
About the role:
- 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.
- BS/BA; MBA preferred. 5-8+ years overall experience in drug development with at least 3 years project management experience in the biopharmaceutical industry is required
- Experience in Quality Operations in a drug development environment is required
- Knowledge/experience in managing/implementing GxP projects and systems. Experience working within the framework of a validated project implementation plan and knowledge of validation deliverables is highly desirable
- Knowledge/experience in working with Quality-related solutions and systems: document management systems, quality systems (audit, CAPA, deviations, change control).
- Ability to effectively partner with Business Process Owners in driving project selection and implementation through effective gathering and analysis of user requirements and capabilities needs.
- Familiarity with Veeva Vault Quality solutions --- ability to administer and develop within this platform highly desirable
- Independently motivated, detail oriented, and good problem-solving ability
- Excellent organizational skills, capable of multi-tasking in an extremely fast-paced environment with changing priorities
- Excellent communication skills and ability to influence across multiple functions
- Ability to work effectively in a collaborative team environment, where results are achieved through influence and the incorporation of multiple points of view
- Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself