Senior Digital Systems Quality Assurance Engineer

Axiom Path • Bridgewater Township, NJ

2d • Hybrid

About The Position

Join a patient-focused biopharmaceutical organization whose Quality and technology teams help ensure that the digital platforms supporting drug development, clinical operations, laboratory activities, and commercialization remain compliant and dependable. This role sits within a collaborative Digital Systems Quality Assurance function that works closely with computerized system validation, Information Technology, business system owners, and external technology partners. The team supports a varied portfolio of enterprise, clinical, laboratory, cloud-based, and emerging AI-enabled GxP applications in a fast-moving regulated environment.

Requirements

• Bachelor's degree in life sciences, engineering, computer science, or a related field preferred.
• Five or more years of directly relevant Quality Assurance or computerized system validation experience in an FDA-regulated pharmaceutical or biotechnology environment; seven or more years preferred.
• Hands-on experience providing QA oversight for GxP computerized systems.
• Thorough working knowledge of 21 CFR Part 11 and EU GMP Annex 11.
• Strong understanding of ISPE GAMP 5 and risk-based computerized system lifecycle principles.
• Experience reviewing validation plans, requirements, specifications, protocols, test scripts, traceability documentation, and summary reports.
• Experience evaluating computerized system risks related to patient safety, product quality, and data integrity.
• Working knowledge of FDA Computer Software Assurance principles.
• Experience with change control, deviations, CAPAs, periodic reviews, supplier quality, or inspection readiness.
• Experience supporting enterprise, clinical, or laboratory GxP platforms.
• Understanding of SaaS and cloud-hosted system quality oversight.
• Strong critical-thinking, collaboration, communication, accountability, and stakeholder-management skills.
• Ability to work independently in a hands-on role while constructively challenging stakeholders when quality or compliance risks arise.

Nice To Haves

• Familiarity with systems such as Veeva Vault, ServiceNow, Qlik, Entra ID, EDC, IRT, eTMF, CTMS, LIMS, CDS, ELN, or Empower is beneficial.
• Awareness of validation and control principles for AI-enabled GxP systems is preferred.
• ASQ CSQE, CQA, or CQE certification is beneficial.

Responsibilities

• Provide independent QA oversight for GxP computerized systems throughout implementation, operation, maintenance, enhancement, and retirement.
• Help ensure that enterprise, clinical, and laboratory systems remain validated, compliant, and in a controlled state.
• Review and approve validation and lifecycle deliverables for completeness, quality, procedural alignment, and regulatory compliance.
• Apply 21 CFR Part 11, EU GMP Annex 11, ISPE GAMP 5, and risk-based validation principles to computerized systems and system changes.
• Evaluate patient-safety, product-quality, data-integrity, and compliance risks associated with new systems, enhancements, and operational changes.
• Review change controls, deviations, CAPAs, periodic reviews, supplier documentation, and other quality records.
• Partner with CSV, IT, business system owners, and vendors to develop practical solutions that support business objectives without compromising quality.
• Support inspection readiness, supplier qualification, regulatory audits, and ongoing lifecycle compliance.
• Provide quality oversight for SaaS, cloud-hosted, and AI-enabled GxP systems.
• Help define appropriate controls and validation evidence for AI solutions used to support GxP activities and decision-making.
• Contribute to procedures, work instructions, training, and continuous improvements related to digital quality and computerized system lifecycle management.

Benefits

• Hybrid opportunity based in Bridgewater, New Jersey, with approximately one to two onsite days per week.
• Full-time W2 consulting engagement supporting high-visibility digital quality initiatives.
• Exposure to enterprise, clinical, laboratory, SaaS, cloud, and AI-enabled GxP platforms.
• Opportunity to work across Quality, CSV, IT, business, and vendor teams.
• Hands-on role with meaningful responsibility for patient safety, product quality, data integrity, and regulatory compliance.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior