Sr. Engineer, Digital Systems Quality Assurance

629716 Sr. Engineer, Digital Systems Quality Assurance

6-month contract

Bridgewater, NJ

Required Skills:

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

Position Summary:

· 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.

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***