Beam Therapeutics · 11 hours ago
Specialist, GxP Compliance & Data Integrity
Durham, NC
Full-time
Onsite
Senior Level, Lead/Staff
$105K/yr - $145K/yr
8+ years expBeam Therapeutics is seeking a highly skilled Specialist I/II to join their growing Digital Quality & Data Integrity team. This role focuses on advanced computerized systems quality assurance and data integrity, ensuring compliance with GxP and regulatory standards while collaborating with various teams to influence digital strategies and drive innovation.
BiotechnologyGeneticsMedicalTherapeutics
Hiring Manager
Sarah Oleson
Responsibilities
Oversee risk-based Computerized System Validation (CSV)/Computerized Software Assurance (CSA) activities across Manufacturing, QC, IT, Automation and Global Platforms, ensuring 21 CFR Part 11/Annex 11 and Beam’s internal policies and procedures
Support review and approval of validation lifecycle documents including but not limited to SIA, URS/SRS, CS, FDS, IQ, OQ, PQ, RTM and VSR, for embedded computerized systems and global platforms
Support authoring of CSV lifecycle and test documents, risk assessments and gap assessments as required
Collaborate with IT system owners, business systems owners, validation and product quality to deploy robust data integrity controls across systems and processes
Participate in Change Management activities to ensure controlled evaluation, qualification, and deployment of changes
Serve as SME and/or Quality approver on QMS records including change controls, continuous improvements, CAPAs, deviations and supplier qualification associated with computerized systems and data integrity
Review and ensure validation compliance for infrastructure systems such as DeltaV, MES, OSI PI, BAS, Clinical and Cloud systems
Act as data integrity SME by ensuring the enforcement of ALCOA+ principles and identifying critical data risks across manufacturing processes, QC methods, and computerized systems
Actively participate in the development of data integrity gap assessment program and assessment tools and eventual gap remediation activities by supporting identification of short term and long term mitigation strategies
Contribute to improvements in CSV/CSA and data integrity policies and procedures, user/functional group SME training and guidance
Support periodic review activities - periodic reviews of computerized systems, user access reviews, audit trail reviews, periodic validation reviews and periodic procedure reviews and updates to maintain compliance
Qualification
Required
Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related field with 10+ years of relevant experience; or Master's degree in the same fields with 8+ years of relevant experience
Experience working in Quality Assurance, Validation, or IT Quality Assurance roles within the biotechnology or pharmaceutical industry
Experience working with systems like DeltaV, OSI PI, BAS, Kneat, Veeva, MES or comparable automation and data systems
Experience with supplier management program for computerized system suppliers
Proven ability to implement cross-functional remediation plans aligned with the regulatory expectations for CSV/CSA and data governance
Excellent written and verbal communication skills; ability to collaborate across functions
Ability to work independently, manage prioritize competing priorities, and maintain compliance under tight timelines
Ability to lead and implement changes in QA capacity in a fast-paced and diverse environment
This position will require to be on-site at Beam's RTP location
Preferred
Familiarity working with manufacturing platforms such as Rotea, Sepax, LOVO, Cue, Prodigy, MaxCyte, Skid Controllers and platform integrations with DeltaV
Experience with analytical instruments such as Spectramax, Zetasizer, MACSQuant, SoloVPE, BacT with MYLA software, and other laboratory instruments
Strong operational knowledge of risk-based tools, ALCOA+ principles, FDA and MHRA data integrity guidance, and 21 CFR Part 11/Annex 11 regulations
Prior experience working as a QA reviewer for embedded computerized systems – manufacturing equipment(s) and analytical instruments
Company
Beam Therapeutics
Beam Therapeutics is a biotechnology company developing precision genetic medicines through the use of base editing technology.
501-1000 employees
H1B Sponsorship
Beam Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (9)
2023 (12)
2022 (9)
2021 (7)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
$1.19B2025-03-10Post Ipo Equity· $500M
2021-01-19Post Ipo Equity· $260M
2020-02-11Post Ipo Equity· $207M
Leadership Team
John Evans
CEO
Christine Bellon
Chief Legal Officer
Recent News
2025-12-16
2025-12-09
Company data provided by crunchbase