Principal Engineer, Digital Regulatory Assurance (Life Sciences)

📋 Description

• Provide quality and regulatory oversight for GxP-relevant applications, infrastructure platforms
• Act as a trusted advisor on SLC, Computer Software Assurance (CSA), validation, infrastructure
• Lead compliance monitoring activities across assigned portfolios, including periodic reviews, audit
• Partner with business and technology teams to ensure quality, compliance, and validation
• Provide guidance on validation strategies, risk assessments, regulatory characterizations
• Lead audit and inspection readiness efforts, including preparation activities, evidence reviews

🎯 Requirements

• Bachelor’s Degree in Engineering, Computer Science, Life Sciences, or related discipline with 7
• Strong experience in process optimization, AI enabled solutioning, audit-readiness, CAPAs and
• Experience supporting regulatory audits/inspections and implementing quality monitoring solutions.
• Project management, analytical, and documentation skills; ability to create knowledge materials and
• Knowledge of Computer Software Assurance (CSA), digital transformation in quality, and contemporary
• Expert knowledge of GxP regulations required.

🎁 Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick)
• This job is eligible to participate in our long-term incentive programs.