Sr. Engineer, Digital Systems Quality Assurance

• 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.

• GxP Computer System Validation
• 21 CFR PART 11 COMPLIANCE
• EUDRALEX VOLUME 4 ANNEX 11 COMPLIANCE, * 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.

Education

• 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 rate is commensurate with experience. Target pay rate range is $50-60/hr