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

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, Service Now, Qlik, Entra , and other regulated systems
, ensuring compliance with FDA, EMA, ICH, GAMP 5, and Computer Software Assurance (CSA) requirements.

• 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:
• Service Now
• Qlik

• Review and approve validation lifecycle documentation including:
• User Requirement Specifications (URS)
• Functional Specifications (FS)
• Validation Plans
• 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

• Review and approve:
• Change Controls
• Deviations
• CAPAs
• Periodic Reviews
• Supplier Quality documentation
• Drive continuous compliance and quality improvements across computerized systems.

• 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.

• 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.

• 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.

• 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

Experience with one or more of the following:

• Service Now
• Qlik
• Clinical Systems (EDC, CTMS, eTMF, IRT)
• Laboratory Systems (LIMS, CDS, ELN, Empower)

• 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.