Leads the strategic integration of Software Quality Assurance (SQA), Compliance, and BTS Technology Enablement teams delivering the Technology Solution Lifecycle (TSL) automation tools. Responsible for ensuring pharmaceutical regulatory requirements (GxP, CSV, Part 11, Annex 11) are accurately interpreted, translated, and embedded into technology practices and CI/CD pipelines. Accountable for identifying strategic business opportunities, shaping compliant technology solutions, leading process modernization, and ensuring alignment of digital quality engineering with business and regulatory expectations across multiple business areas. 

Responsibilities

•  Lead as the primary liaison between SQA and Compliance leaders and BTS technology enablement teams; broker services, align stakeholders, and resolve interdependencies across multiple business areas. 
• Responsible for analyzing business strategies, processes, and regulatory drivers across business units to identify needs and opportunities for quality and compliance improvement enabled by technology. 
• Accountable for interpreting and translating compliance and quality requirements (GxP, CSV, Part 11, Annex 11, SLC) into epics, user stories, acceptance criteria, functional specifications, and process changes. 
• Lead development, maintenance, and validation of traceability matrices linking requirements, controls, system design, and verification evidence; ensure inspection-ready documentation. 
• Partner with development, DevOps, and automation teams to embed compliant quality controls into TSL tools, including risk profiling, requirements/design management, CI/CD, testing, deployment, and monitoring. 
• Lead significant cross-functional improvement programs, including shift-left testing, risk-based validation, automation, and process simplification. 
• Responsible for ensuring compliance with Corporate and Divisional policies, standards, and governance; evaluate solution alternatives using standard IS methodologies and assess regulatory impacts. 
• Lead integration efforts with BTOs/BTS teams, maintain strong cross-functional relationships, broker services, manage interdependencies, and support customer engagement. 
• Lead a significant area of work with technical, financial, and quality accountability; establish objectives, delegate assignments, develop talent, and deliver training and awareness on compliant quality engineering and regulatory changes.