IT Business Analyst, Regulatory & Quality Systems

Beam TherapeuticsCambridge, MA
11h

About The Position

Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases. Position Overview: We are seeking a highly skilled IT Systems Analyst to serve as the primary IT resource supporting Beam’s portfolio of Quality and Regulatory Systems. You will play a key role in both the implementation of new application modules and ongoing operational support, including defining requirements, designing solutions, performing application configuration, system documentation, testing, and troubleshooting activities.

Requirements

  • 3-5 years of successful IT experience in system development lifecycle (SDLC) activities (requirements, design, configuration, validation/testing, and support).
  • Experience implementing or supporting one or more quality and/or regulatory computerized systems, preferably Veeva Quality.
  • Experience with Computer Systems Validation (CSV).
  • Experience with eliciting business requirements and translating into technical deliverables.
  • Strong analytical and troubleshooting skills.

Nice To Haves

  • Experience with Quality Systems workflows (Controlled Document Management, Training, Change Control, Deviations, etc.) preferred.
  • Some Project Management experience is helpful.

Responsibilities

  • Act as the primary liaison between IT and Quality and Regulatory teams.
  • Lead the implementation, enhancement, and support of Quality and Regulatory IT systems.
  • Serve as primary operational support to resolve any system related issues.
  • Gather and document business requirements and ensure these are translated into high quality technical solutions that meet the needs of our organization.
  • Lead continuous improvement efforts for existing systems. Partner closely with business stakeholders to collect and prioritize enhancement requests. Stay up to date on new technologies and best-practices and make recommendations for potential improvements.
  • Support validation and change management activities, including contributing to requirements documentation, test scripts, and change control documentation.
  • Support the larger IT organization by assuming other duties and responsibilities, as assigned.
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