Non-IT Project Management - Associate-Senior-C

Senior QA Specialist - Computer Systems Validation (CSV) & GxP Quality Assurance

Location

Remote / Hybrid Employment Type Contract / Permanent Industry Pharmaceutical / Biotechnology / Life Sciences

About the Role

We are seeking an experienced Senior QA Specialist - Computer Systems Validation (CSV) to provide Quality Assurance oversight for GxP computerized systems across their full lifecycle. This role will partner closely with IT Quality Validation Business Process Owners and external vendors to ensure computerized systems remain compliant validated and inspection-ready in support of patient safety product quality and regulatory compliance. The successful candidate will act as a key Quality representative for enterprise GxP platforms including Veeva Vault ServiceNow Qlik Entra ID and other regulated systems ensuring compliance with FDA EMA ICH GAMP 5 and Computer Software Assurance (CSA) requirements.

Key Responsibilities

Quality & Compliance Oversight Provide QA oversight for GxP computerized systems throughout implementation operation maintenance enhancement and retirement. Ensure systems remain in a validated state and compliant with applicable regulations and industry standards. Act as the primary Quality representative for enterprise GxP systems including Veeva Vault QMS Veeva RIM Veeva MedComms Veeva MedInquiry ServiceNow Qlik Microsoft Entra ID Computer Systems Validation (CSV) Review and approve validation lifecycle documentation including User Requirement Specifications (URS) Functional Specifications (FS) Validation Plans Risk Assessments IQ/OQ/PQ Protocols Test Scripts Validation

Summary

Reports Apply risk-based validation strategies using FDA Computer Software Assurance (CSA) ISPE GAMP 5 Data Integrity principles Support validation activities for SaaS platforms Cloud-hosted systems On-premise applications Quality Systems Support Review and approve Change Controls Deviations CAPAs Periodic Reviews Supplier Quality documentation Drive continuous compliance and quality improvements across computerized systems. Regulatory & Inspection Readiness Ensure compliance with 21 CFR Part 11 EU Annex 11 FDA Guidance ICH Guidelines GAMP 5 Participate in regulatory inspections audits and audit readiness activities. Support supplier qualification and vendor audits. Data Integrity & Risk Management Assess system changes and enhancements for Patient safety impact Product quality risk Data integrity implications Ensure compliance with ALCOA+ principles. Support implementation of risk-based validation approaches aligned with business needs. AI & Emerging Technologies Support validation and quality oversight for AI/ML-enabled solutions. Evaluate AI-enabled systems using risk-based approaches aligned with current industry guidance and GAMP AI frameworks. Collaborate with stakeholders on governance and compliance for emerging technologies.

Required Skills & Experience

Essential Bachelor's degree in Life Sciences Computer Science Engineering Quality or related discipline. Minimum 7 years of experience within Pharmaceutical Biotechnology Life Sciences FDA-regulated environments Strong experience in Computer Systems Validation (CSV) GxP Compliance Quality Assurance Validation Lifecycle Management Hands-on knowledge of 21 CFR Part 11 EU Annex 11 FDA CSA ISPE GAMP 5 Data Integrity (ALCOA+) Experience supporting Change Controls Deviations CAPAs Audit Readiness Supplier

Qualification

Preferred Systems Experience Experience with one or more of the following Veeva Vault QMS Veeva RIM Veeva MedComms Veeva MedInquiry ServiceNow Qlik Microsoft Entra ID Clinical Systems (EDC CTMS eTMF IRT) Laboratory Systems (LIMS CDS ELN Empower)

Preferred Qualifications

ASQ Certifications CSQE CQE CQA Experience supporting SaaS and cloud-based GxP platforms. Experience supporting AI/ML platform validation. Regulatory inspection support experience. Strong stakeholder management and communication skills.