Specialist, GxP Compliance & Data Integrity

Beam Therapeutics(25 days ago)

North CarolinaOnsiteFull TimeSenior$105,000 - $145,000Digital Quality & Data Integrity

About this role

The Specialist I/II on the Digital Quality & Data Integrity team will lead computerized systems quality assurance and data integrity efforts across embedded systems and global platforms (SaaS, IaaS, PaaS). The role partners cross-functionally with Manufacturing, QC, Validation, IT, and Automation to shape validation lifecycle activities, data governance, and enterprise digital strategies. The position focuses on ensuring GxP and regulatory compliance to protect patient safety and product quality while driving process improvements and remediation efforts.

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Required Skills

CSV
CSA
Validation
Data Integrity
Risk Assessment
Change Management
Supplier Management
Audit Trails
ALCOA+
Regulatory Compliance

+4 more

Qualifications

Bachelor's Degree (Engineering)
Bachelor's Degree (Computer Science)
Bachelor's Degree (Life Sciences)
Master's Degree (Engineering)
Master's Degree (Computer Science)
Master's Degree (Life Sciences)

About Beam Therapeutics

beamtx.com

Beam Therapeutics is a clinical-stage biotechnology company based in Cambridge, MA, pioneering precision genetic medicines using its proprietary base editing platform to make precise single‑base DNA changes without creating double‑strand breaks. The company advances both in vivo and ex vivo programs across hematology, rare genetic diseases, and oncology, moving several candidates toward clinical development. Beam combines engineered editors, delivery technologies, and extensive safety profiling to create durable, potentially one‑time treatments and partners with academic and industry collaborators to accelerate translation.