Abbott Laboratories seeks an IT Quality & Regulatory Assurance Manager to lead IT compliance across biotechnology and pharmaceutical operations. In this role, you will own IT quality frameworks, ensuring GxP, FDA, 21 CFR Part 11, and ISO compliance for critical systems. You will drive computer system validation, change control, and risk management, and lead audit readiness for internal and external inspections. Partnering closely with global IT, QA, and business teams, you will embed quality by design, implement continuous improvement, and provide training in a collaborative, mission-driven environment that supports career growth and work-life balance.
Responsibilities
- Lead IT quality and regulatory assurance activities for Gx
- P-relevant systems and processes.
- Develop, implement, and maintain IT quality management procedures and documentation.
- Ensure compliance with FDA, 21 CFR Part 11, Gx
- P, ISO and other applicable regulations and standards.
- Oversee computer system validation, change control, and risk management for IT solutions.
- Plan and support internal and external audits and inspections, driving remediation and CAPAs.
- Partner with IT, QA, and business stakeholders to embed quality by design into projects.
- Monitor, analyze, and report on IT quality metrics and continuous improvement initiatives.
- Provide training and guidance on IT quality and regulatory requirements to teams.
- Review and approve IT deliverables, including requirements, testing, and validation packages.
- Collaborate globally to harmonize IT quality practices and support corporate initiatives.
Required Skills
- IT quality management
- Gx
- P compliance21 CFR Part 11
- Computer system validation (CSV)
- Change control and configuration management
- Risk management in regulated environments
- Audit planning and execution
- CAPA management
- ISO 9001/13485 standards
- Regulated documentation and SOPs
- Quality metrics and reporting
- Project management
- Stakeholder management
- Training on compliance and quality processes
- Medical device/pharma regulatory knowledge
