Manager, IT Quality & Compliance

Essential Functions

• IT Validation & CSV/CSA Execution
• Execute Computer Software Assurance (CSA) and Computer System Validation (CSV) activities for GxP systems.
• Support validation lifecycle activities (planning, testing, documentation, release, and change management).
• Provide ITQA oversight for implementation of GxP systems.
• Support data migration validation (reconciliation, traceability, and verification).
• Audit & Inspection Readiness
• Perform internal IT CSV audits to ensure regulatory and procedural compliance.
• Support and execute GxP vendor audits.
• Prepare audit documentation, evidence packages, and formal audit reports.
• Support regulatory inspections and inspection readiness activities.
• Vendor Management & Oversight
• Conduct vendor qualification and periodic vendor audits.
• Support vendor risk assessments and compliance monitoring.
• Ensure vendors meet GxP, data integrity, and security requirements.
• Periodic Reviews & Compliance Monitoring
• Perform periodic reviews of GxP systems to maintain validated state.
• Identify compliance gaps and drive remediation.
• Support continuous audit and compliance monitoring programs.
• Investigations & CAPA Management
• Support IT investigations (deviations, incidents, compliance gaps).
• Author and manage CAPAs, ensuring timely closure and effectiveness.
• Promote cross-functional collaboration to implement corrective and preventive actions.
• Documentation & SOP Development
• Author and maintain IT and QA SOPs, policies, and work instructions.
• Ensure alignment with GxP and 21 CFR Part 11 requirements.
• Support continuous improvement of documentation and processes.
• Data Integrity, Cybersecurity & Infrastructure Alignment
• Support implementation of data integrity controls (ALCOA+).
• Partner with IT Security to align compliance with cybersecurity controls (access, logging, monitoring).
• Ensure infrastructure supporting GxP systems is maintained in a secure and compliant state (patching, backup, recovery).
• Identify and escalate risks related to data integrity, cybersecurity, and infrastructure.
• Training & Cross-Functional Collaboration
• Support IT Quality & Compliance training initiatives.
• Collaborate across IT, Security, Quality, and business teams.

Requirements

• Bachelor’s degree in IT, Quality, Life Sciences, or related field and minimum 5 years of experience in IT Quality, CSV/CSA, or compliance in a GxP environment. Other combinations of education and/or experience may be considered.
• Hands-on experience with:
• IT system validation (CSV/CSA)
• Internal and vendor audits
• Periodic reviews of GxP systems
• Vendor management and oversight
• Data migration validation
• Experience supporting or working with laboratory (GxP lab) and manufacturing systems (e.g., MES, LIMS, lab instruments)
• Experience with Veeva, ERP systems, or regulated SaaS platforms
• Experience supporting or implementing GxP systems from a QA perspective
• Strong knowledge of GxP, 21 CFR Part 11, and data integrity principles
• Experience authoring SOPs, validation documentation, CAPAs, and investigations

Preferred

• Experience in life sciences or biotech environments.
• Experience writing and presenting audit reports and familiarity with risk management frameworks.
• Exposure to QSC (Quality, Security, Compliance) integration and knowledge of data governance and data integrity practices.
• Working knowledge of cybersecurity (access control, data protection, incident response).
• Exposure to IT security and infrastructure controls (patching, system hardening).
• Experience using AI tools for research, analysis, and process optimization.