Note: The job is a remote job and is open to candidates in USA. i-Pharm Consulting is seeking a Senior QA Specialist to provide Quality Assurance oversight for GxP computerized systems throughout their lifecycle. The role focuses on Computer Systems Validation, regulatory compliance, inspection readiness, data integrity, quality systems support, and oversight of AI/ML-enabled solutions.
Responsibilities
- 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:
- Review and approve validation lifecycle documentation including:
- Apply risk-based validation strategies using:
- Support validation activities for:
- Review and approve:
- Drive continuous compliance and quality improvements across computerized systems
- Ensure compliance with:
- Participate in regulatory inspections, audits, and audit readiness activities
- Support supplier qualification and vendor audits
- Assess system changes and enhancements for:
- 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
Skills
- • 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
- • 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)
- • 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
Benefits
- Remote / Hybrid work arrangement
Company Overview