Quality & Compliance Validation Specialist (IT Platforms, GxP)

Role – Quality & Compliance Validation Specialist (IT Platforms, GxP)

Location: Plainsboro NJ – 3days Hybrid

Key responsibilities

IT platform and application governance

• Apply and enforce IT platform and application governance processes across the delivery lifecycle (intake, design, build, release, change, retirement).
• Ensure platforms and applications follow the client's SDLC, change management and release controls.
• Act as the quality and compliance point of contact for delivery teams, flagging gaps early.
• Review IT solution designs from a documentation governance perspective: confirm each solution has the right architecture, design, risk and validation artifacts before build and go-live.

GxP validation and qualification

• Plan and execute validation for GxP-relevant systems using CSV/CSA approaches (GAMP 5 risk-based).
• Lead platform, environment and sandbox qualification (IQ/OQ/PQ), including qualification of new tools before production use.
• Author and review validation plans, risk assessments, requirements traceability matrices, test scripts and validation summary reports.
• Support 21 CFR Part 11 and EU Annex 11 compliance for electronic records and signatures.

IT process and platform documentation

• Create, maintain and review IT process documentation: SOPs, work instructions, system descriptions, user requirements, functional/design specifications, operational runbooks.
• Maintain regular platform documentation: configuration records, access reviews, periodic reviews, change records and release notes.
• Keep documentation audit-ready and version-controlled in the client's document management system.

Approvals and e-signature workflows

• Route deliverables through the client's approval processes (QA review, business owner, system owner, IT quality sign-off).
• Manage DocuSign-based review and e-signature workflows, tracking approvals to closure.
• Track deviations, CAPAs and change controls through to sign-off.

Data privacy and AI governance

• Ensure solutions comply with GDPR and applicable data privacy requirements (DPIAs, data classification, data handling).
• Apply AI governance controls to AI/GenAI solutions: model risk assessment, intended-use documentation, human oversight, monitoring and audit trail.
• Support internal audits and client/regulatory inspections with evidence and documentation.
• Coordinate with the client's IT security, data governance and privacy teams to secure reviews, risk sign-offs and approvals for each solution.

Required skills and experience

• 6–10 years in IT quality, computer system validation (CSV/CSA) or IT compliance in pharma, biotech or life sciences.
• Strong working knowledge of GxP (GMP, Google Cloud Platform, GLP, GDP as applicable), GAMP 5, 21 CFR Part 11 and EU Annex 11.
• Hands-on experience with platform, environment and sandbox qualification (IQ/OQ/PQ) for cloud and SaaS platforms.
• Thorough understanding of IT process documentation: SOPs, URS/FS/DS, traceability matrices, test evidence, validation reports.
• Experience maintaining regular platform documentation: periodic reviews, access reviews, configuration and change records.
• Practical experience with DocuSign (or similar e-signature tools) for controlled document review and approval.
• Awareness of multi-level approval processes: QA, system owner, business owner, change advisory board, release approvals.
• Working knowledge of GDPR and data privacy controls; familiarity with AI governance frameworks (e.g., EU AI Act, NIST AI RMF, internal AI policies).
• Experience with deviation, CAPA and change control processes.
• Clear technical writing and the ability to work with engineers, QA and business stakeholders.
• Awareness of IT solutioning (architecture, integration, cloud and data platforms) from a documentation governance perspective: knowing which artifacts each solution needs and when.
• Proven experience coordinating with security, data governance and privacy teams to obtain reviews and approvals.

Preferred qualifications

• Experience validating data and analytics platforms (Snowflake, Power BI, Azure, AWS) or AI/GenAI solutions in a GxP context.
• Familiarity with ServiceNow, Veeva Vault QualityDocs or similar quality and document management systems.
• Certifications such as ASQ CQA/CSQE, ISPE GAMP training, or ISO 27001 awareness.
• Prior work in a global pharma client environment, ideally Novo Nordisk or a peer top-20 pharma