SR. ENGINEER, DIGITAL SYSTEMS QUALITY ASSURANCE

About the role

Provides quality oversight of GxP computerized systems throughout their lifecycle, ensuring compliance with FDA, EMA, and ICH regulatory requirements in support of patient safety and product quality. Serves as a primary QA partner for Enterprise-level GxP systems — including Veeva Quality (Vault QMS), Veeva RIM, Veeva MedComms, Veeva MedInquiry, ServiceNow, Qlik, and Entra ID — supporting implementation, validation, and ongoing lifecycle management. Maintains foundational understanding of GxP Computer systems validation principles to support cross-functional collaboration and holistic quality oversight. Partners with IT, business, CSV and vendor teams to apply risk-based approaches, maintain validated state, and drive continuous compliance. Applies proficiency in key Quality Systems processes including Change Control, Deviation, CAPA, Supplier Quality, Internal/External Audit, and Quality Complaints. Contributes to the organization’s digital quality strategy as a subject matter expert in computerized system validation and lifecycle management. Driven by a genuine commitment to patient safety and a passion for ensuring that the digital systems supporting drug development and commercialization are compliant, reliable, and trustworthy.

Responsibilities

• Provide QA oversight for GxP computerized systems across their full lifecycle (implementation, operation, maintenance, and retirement) to ensure compliance with FDA, ICH, and EU regulations.
• Serve as the primary QA point of contact for Enterprise GxP systems (Veeva Vault QMS/RIM/MedComms/MedInquiry, ServiceNow, Qlik, Entra ID), supporting validation, change control, and lifecycle management activities.
• Review and approve CSV deliverables including User Requirement Specifications (URS), Functional Specifications (FS), validation plans, protocols, test scripts, and summary reports.
• Ensure practical compliance with 21 CFR Part 11 and Eudralex Volume 4 Annex 11 as applied to electronic records, electronic signatures, audit trails, and system access controls.
• Independently assess GxP risk of systems and system enhancements — evaluating patient safety impact, product quality risk, and data integrity implications — and define a right-sized validation strategy applying FDA CSA and ISPE GAMP 5 principles.
• Perform QA review and approval of change control records, deviations, CAPAs, and periodic reviews for GxP computerized systems.
• Support development, review, and approval of SOPs, work instructions, and procedural documents related to computerized system lifecycle management.
• Provide QA support during supplier qualification, audits, and system implementation projects, including SaaS and cloud-based solutions.
• Participate in inspection readiness activities and provide direct support during regulatory inspections and audits.
• Monitor industry trends and regulatory updates (FDA, EMA, ICH, ISPE/GAMP) to ensure QA practices remain current.
• Provide training and guidance to business and IT stakeholders on quality and compliance expectations for GxP computerized systems.
• Support validation and quality oversight of AI/ML-enabled computerized systems, applying risk-based CSA principles in alignment with ISPE GAMP AI guidance.

Skills

• In-depth knowledge of 21 CFR Part 11 and Eudralex Volume 4 Annex 11, with practical experience applying these to electronic records, electronic signatures, audit trails, and access controls.
• Strong working knowledge of ISPE GAMP 5 principles, including software categorization (Categories 1–5), supplier assessment, and risk-based lifecycle validation.
• Demonstrated understanding of FDA Computer Software Assurance (CSA) guidance and ability to define right-sized validation strategies aligned to patient safety risk, product quality, and data integrity.
• Hands-on experience with Enterprise GxP systems; direct experience with one or more of the following strongly preferred: Veeva Vault (QMS, RIM, MedComms, MedInquiry), ServiceNow, Qlik, or Entra ID.
• Working knowledge of Clinical Systems (e.g., EDC, IRT, eTMF, CTMS) and/or QC Laboratory Systems (e.g., LIMS, CDS, ELN, Empower) validation principles.
• Experience with on-premise, SaaS, and cloud-hosted systems, including supplier qualification and audit activities.
• Solid understanding of data integrity principles and ALCOA+ requirements for electronic records and computerized systems.
• Awareness of emerging AI/ML validation frameworks (e.g., ISPE GAMP AI Guide) and their application to GxP-regulated AI systems preferred.
• Quality Professional Certifications (e.g., ASQ CSQE, CQE, CQA) preferred.

Requirements

• Bachelor’s degree in Life Sciences, Computer Science, Engineering, or a related field preferred.
• Minimum 7 years of experience in Quality Assurance and/or Validation within the FDA-regulated pharmaceutical or biotechnology industry, with a demonstrated track record of supporting GxP computerized system lifecycle management.
• Demonstrated experience supporting regulatory inspections and audit readiness activities.
• Experience with quality systems processes including Change Control, Deviation management, CAPA, and Supplier Quality.

Pay

$53–63/hr based on experience