Responsibilities
- Plan, execute, and summarize GxP audits with a focus on technology and computerized systems for clients in pharmaceutical, biotechnology, and healthcare sectors
- Provide advisory services on regulated technologies, covering governance structures, system monitoring, risk evaluations, compliance gap reviews, and preparation for regulatory inspections
- Assist clients in adopting and managing new regulatory requirements for AI and machine learning in GxP environments, including risk-based quality assurance frameworks
- Track and analyze evolving international regulatory standards and industry developments in digital systems, AI governance, data management, and technology-driven compliance
- Offer strategic and operational guidance on emerging technologies and digital innovation in regulated GxP settings
- Lead the expansion and development of the Regulatory Technology service offering across global life sciences clients
- Work with internal specialists in clinical, pharmacovigilance, laboratory, and manufacturing compliance to integrate digital solutions into existing service portfolios
- Advance business growth through client interaction, proposal creation, industry speaking, and participation in professional conferences
- Guide and develop team talent within the practice while shaping its long-term strategy and capacity for scaling
