Specialist, GxP Compliance & Data Integrity

Position Overview:

Beam is seeking a highly skilled Specialist I/II to join our growing Digital Quality & Data Integrity team and play a pivotal role in shaping the future of digital compliance. Unlike traditional QA roles, this position focuses on advanced computerized systems quality assurance and data integrity across local embedded computerized systems and global platforms—including SaaS, IaaS, and PaaS—critical to our digital transformation. As a trusted Subject Matter Expert, you will partner with Manufacturing, Quality Control, Validation (CQV and CSV), IT, and Automation teams to ensure seamless qualification, validation, and automation activities that meet GxP and regulatory standards. This is your opportunity to influence enterprise-wide digital strategies, drive innovation, and make a measurable impact on patient safety and product quality.

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.

Qualifications:

• 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.
• Familiarity working with manufacturing platforms such as Rotea, Sepax, LOVO, Cue, Prodigy, MaxCyte, Skid Controllers and platform integrations with DeltaV is preferred.
• Experience with analytical instruments such as Spectramax, Zetasizer, MACSQuant, SoloVPE, BacT with MYLA software, and other laboratory instruments.
• Experience with supplier management program for computerized system suppliers.
• Strong operational knowledge of risk-based tools, ALCOA+ principles, FDA and MHRA data integrity guidance, and 21 CFR Part 11/Annex 11 regulations is preferred.
• Prior experience working as a QA reviewer for embedded computerized systems – manufacturing equipment(s) and analytical instruments.
• 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.