Bachelor's degree in life sciences, engineering, computer science, or related field preferred.
5+ years of Quality Assurance or computerized system validation experience in FDA-regulated environments; 7+ years preferred.
Hands-on experience with QA oversight for GxP computerized systems.
Thorough knowledge of 21 CFR Part 11 and EU GMP Annex 11.
Strong understanding of ISPE GAMP 5 and risk-based lifecycle principles.
Experience with validation plans, specifications, and compliance documentation.
Familiarity with systems like Veeva Vault, ServiceNow, and cloud-hosted platforms.
Responsibilities
Provide independent QA oversight for GxP computerized systems throughout their lifecycle.
Ensure enterprise, clinical, and laboratory systems remain validated and compliant.
Review and approve validation and lifecycle deliverables for quality and regulatory compliance.
Apply regulatory principles to computerized systems and system changes.
Evaluate risks related to patient safety, product quality, and compliance for new systems.
Review change controls, deviations, and quality records.
Partner with teams to develop solutions that meet business objectives without compromising quality.
Benefits
Hybrid work opportunity with onsite days in Bridgewater, NJ.
Full-time W2 consulting engagement.
Exposure to high-visibility digital quality initiatives.
Hands-on role with significant responsibility for patient safety and product quality.
Engagement limited to W2 arrangements only.
Full Job Description
Job Description What s In Store for You
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.
Engagement: W2 only; no C2C or 1099 arrangements.
How You Will Make an Impact
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.
Requirements
Do You Bring Proven Success in Digital Systems Quality Assurance?
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.
Familiarity with systems such as Veeva Vault, ServiceNow, Qlik, Entra ID, EDC, IRT, eTMF, CTMS, LIMS, CDS, ELN, or Empower is beneficial.
Understanding of SaaS and cloud-hosted system quality oversight.
Awareness of validation and control principles for AI-enabled GxP systems is preferred.
ASQ CSQE, CQA, or CQE certification is beneficial.
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.
