Senior Digital Systems Quality Assurance Engineer 3643945

Job Description

Job Description

Be Part of a High-Performing Team

Join a patient-focused biopharmaceutical organization dedicated to transforming the lives of people living with serious and rare diseases. The organization promotes collaboration, accountability, integrity, scientific innovation, and open communication while empowering employees to challenge established approaches and make thoughtful, data-informed decisions. Its people-first culture has received repeated workplace recognition within the biopharmaceutical industry.

This opportunity supports a Digital Systems Quality Assurance team responsible for ensuring that enterprise technology platforms used in drug development, quality operations, and commercialization remain compliant, reliable, and inspection-ready. The environment is highly cross-functional, bringing together Quality, IT, validation, business, and vendor teams to implement risk-based quality practices across modern SaaS, cloud, and enterprise systems.

What’s In Store for You

• Six-month W2 consulting engagement with the potential to contribute to highly visible enterprise quality initiatives.
• Full-time schedule of 40 hours per week.
• Onsite opportunity in Bridgewater, New Jersey.
• Exposure to enterprise platforms including Veeva Vault, ServiceNow, Qlik, and Microsoft Entra ID.
• Opportunity to influence digital quality strategy and the validation of emerging AI- and machine-learning-enabled systems.
• Collaboration with experienced Quality, IT, CSV, business, and supplier teams.
• Engagement: W2 only; no C2C or 1099 arrangements.

How You Will Make an Impact

• Provide independent Quality Assurance oversight for GxP computerized systems throughout implementation, operation, maintenance, enhancement, and retirement.
• Serve as a primary QA partner for enterprise platforms such as Veeva Vault QMS, Veeva RIM, Veeva MedComms, Veeva MedInquiry, ServiceNow, Qlik, and Entra ID.
• Review and approve computerized system validation deliverables, including user requirements, functional specifications, validation plans, protocols, test scripts, traceability documentation, and summary reports.
• Apply 21 CFR Part 11 and EU Annex 11 requirements to electronic records, electronic signatures, audit trails, security, and access-control processes.
• Assess patient safety, product quality, and data-integrity risks associated with new systems and system changes.
• Define practical, risk-based validation strategies using FDA Computer Software Assurance and ISPE GAMP 5 principles.
• Review and approve change controls, deviations, CAPAs, periodic reviews, and other quality-system records.
• Support the development and approval of SOPs, work instructions, and computerized system lifecycle procedures.
• Participate in supplier qualification, vendor audits, SaaS implementations, cloud-system assessments, and inspection-readiness activities.
• Provide guidance and training to business and technology stakeholders regarding GxP quality and compliance expectations.
• Support quality oversight and validation strategies for AI- and machine-learning-enabled GxP systems.
• Monitor evolving FDA, EMA, ICH, ISPE, and GAMP expectations and incorporate relevant changes into quality practices.

Do You Bring Proven Success in GxP Digital Systems Quality Assurance?

• Bachelor’s degree in life sciences, engineering, computer science, or a related discipline preferred.
• At least seven years of Quality Assurance, computerized system validation, or digital quality experience within an FDA-regulated pharmaceutical or biotechnology environment.
• Strong experience overseeing the full lifecycle of GxP computerized systems.
• In-depth working knowledge of 21 CFR Part 11 and EU GMP Annex 11.
• Demonstrated ability to apply FDA Computer Software Assurance and risk-based validation principles.
• Strong knowledge of ISPE GAMP 5, including software categorization, supplier assessment, and lifecycle validation.
• Experience reviewing and approving validation plans, requirements, specifications, test scripts, protocols, traceability records, and validation summary reports.
• Practical experience assessing patient safety, product quality, and data-integrity risks.
• Working knowledge of ALCOA+ data-integrity principles.
• Experience with change control, deviation management, CAPA, supplier quality, periodic review, and audit-readiness processes.
• Hands-on exposure to at least one enterprise GxP platform, preferably Veeva Vault, ServiceNow, Qlik, or Entra ID.
• Experience supporting on-premises, SaaS, and cloud-hosted systems.
• Familiarity with clinical platforms such as EDC, IRT, eTMF, or CTMS, or laboratory platforms such as LIMS, CDS, ELN, or Empower.
• Experience supporting supplier qualification activities and regulatory inspections.
• Awareness of emerging AI and machine-learning validation frameworks is preferred.
• ASQ CSQE, CQA, or CQE certification is preferred.
• Strong judgment, documentation, communication, stakeholder-management, and problem-solving abilities.
• Ability to operate independently while partnering effectively with Quality, IT, CSV, business, and vendor stakeholders.