Quality and Regulatory Business Analyst

Job Overview:

The Principal Quality and Regulatory Business Analyst is a senior IT role responsible for supporting and optimizing systems used by Quality Assurance and Regulatory Affairs functions in a regulated environment. This position partners closely with business stakeholders to ensure systems are reliable, efficient, and compliant with applicable regulations. The role focuses on system analysis, requirements gathering, and lifecycle support for multiple enterprise applications. This hybrid position requires four days onsite per week and one day remote.

Job Responsibilities:

• Partner with Quality and Regulatory teams to support business-critical applications
• Analyze, document, and translate business requirements into functional system solutions
• Support systems including Learning Management, Document Management, Laboratory Management, Event Tracking, Supplier Compliance, Materials Compliance, and Regulatory Information Management
• Develop strategies to rationalize and optimize existing systems
• Manage relationships with third-party vendors to ensure service level performance
• Apply Systems Development Life Cycle methodologies, including waterfall and agile
• Ensure systems maintain compliance with US and international regulatory standards
• Participate in staff meetings, project discussions, and cross-functional initiatives
• Build collaborative relationships across IT and business teams to support organizational objectives
• Support validation activities and maintain compliance within a regulated environment

Qualifications:

• Bachelor’s degree in Information Technology, Business, or related field, or equivalent experience
• Ten or more years of information systems experience with Quality and Regulatory applications
• Experience working in a GMP-regulated environment with validation requirements
• Strong systems analysis skills with the ability to manage multiple applications
• Proven ability to gather, document, and translate business requirements into functional solutions
• Experience with Systems Development Life Cycle methodologies, including waterfall and agile
• Strong interpersonal skills with the ability to collaborate across technical and business teams
• Demonstrated ability to manage multiple priorities and projects independently