Senior Analyst - GxP IT QA/CSV in United States at Jobgether

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Analyst - GxP IT QA/CSV in the United States.

This role sits at the intersection of life sciences, IT compliance, and quality assurance, supporting organizations navigating highly regulated environments. You will work on complex Computerized System Validation (CSV) and Computer Software Assurance (CSA) initiatives, ensuring systems used in critical GxP operations remain compliant, secure, and audit-ready. The position involves close collaboration with senior stakeholders to translate regulatory requirements into practical, technology-enabled solutions. You will contribute directly to IT compliance strategy, system validation frameworks, and risk-based quality approaches across global life sciences clients. Operating in a consulting-driven environment, you will lead workstreams, deliver client-ready documentation, and help modernize validation practices. Your work will directly impact data integrity, patient safety, and regulatory compliance across the pharmaceutical and biotech ecosystem.

In this role, you will lead and contribute to IT compliance and quality initiatives across regulated life sciences environments, with a strong focus on CSV, CSA, and GxP systems. You will independently manage workstreams while supporting clients in designing, validating, and improving compliant IT systems and processes.

• Lead IT compliance and quality projects across FDA, EMA, GDPR, and other global regulatory frameworks.
• Manage end-to-end validation lifecycles, including requirements gathering, CSV/CSA execution, implementation, and post-deployment support.
• Facilitate technical and regulatory discussions, ensuring clear documentation of decisions, risks, and action items.
• Develop client-ready deliverables including validation plans, risk assessments, system specifications, and compliance roadmaps.
• Perform IT system audits, data integrity assessments, and gap analyses to identify compliance risks and improvement opportunities.
• Support modernization efforts using automation, SaaS validation approaches, and risk-based compliance methodologies.
• Contribute to business development by identifying opportunities, supporting proposals, and engaging senior client stakeholders.

This role requires strong consulting or industry experience in life sciences IT compliance, with hands-on expertise in regulated environments and system validation practices. You should be comfortable working independently, managing client expectations, and translating complex regulatory frameworks into actionable solutions.

• 3–5+ years of consulting or equivalent experience in IT compliance within the life sciences industry.
• Experience across regulated domains such as GMP, GCP, GLP, GDP, or Pharmacovigilance.
• Hands-on experience with CSV and/or CSA in life sciences functions such as manufacturing, quality, clinical, labs, or supply chain.
• Strong knowledge of regulatory frameworks including 21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA+ data integrity principles.
• Familiarity with enterprise life sciences systems (e.g., Veeva, SAP, TrackWise, Medidata, MasterControl, Lab systems).
• Experience with validation of cloud, SaaS, and/or on-premise infrastructure and applications.
• Strong analytical, communication, and stakeholder management skills, including experience presenting to senior leaders.
• Bachelor’s degree in Computer Science, Information Systems, Life Sciences, or a related field.

• Competitive compensation aligned with experience and expertise.
• Remote-first or flexible work arrangements depending on client engagement needs.
• Exposure to leading global life sciences organizations and cutting-edge regulatory projects.
• Opportunities to work on high-impact CSV/CSA and digital transformation initiatives.
• Career development through mentorship, leadership exposure, and technical upskilling.
• Collaborative consulting environment with strong focus on professional growth.
• Access to complex, high-visibility projects influencing industry compliance standards.