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About this role
Role overview A rare-disease biopharmaceutical organization is hiring a senior leader to serve as the drug-development function's subject-matter expert on end-to-end lifecycle workflows and to drive AI-driven transformation. The role spans mapping current-state processes, identifying high-value AI and automation opportunities, redesigning workflows, and partnering closely with IT to deliver compliant, scalable solutions. This is a hands-on transformation leadership position bridging deep development operations knowledge, process excellence, and enterprise AI.
Responsibilities - Map and analyze end-to-end development lifecycle workflows, documenting pain points, hand-offs, and value drivers across functions. - Systematically evaluate workflows to qualify high-value AI and automation opportunities and build the business case for each. - Re-engineer processes to embed AI effectively, standardizing and simplifying workflows to deliver measurable efficiency and quality gains. - Translate business needs into clear requirements and user stories that IT teams can build against, ensuring accuracy throughout delivery. - Partner with IT on solution design, validating that outputs are scalable, sustainable, and aligned to enterprise standards and platforms. - Ensure redesigned workflows and embedded AI meet GxP, 21 CFR Part 11, and data-integrity requirements, with human accountability and controls built in. - Support testing, user acceptance, and validation, then drive change enablement including documentation, training, and adoption.
Requirements - Bachelor's degree in a scientific, engineering, technology, or related discipline; advanced degree preferred. - 10+ years in biopharma or life sciences drug development or R&D operations with hands-on workflow and process-improvement expertise. - Demonstrated experience mapping, redesigning, and optimizing complex cross-functional workflows; Lean/Six Sigma or BPM experience strongly preferred. - Practical understanding of AI and automation capabilities and how to embed them in operational workflows, with experience defining technical requirements. - Strong working knowledge of GxP, 21 CFR Part 11, data integrity, and validation requirements for computerized and AI-enabled systems. - Proven ability to partner effectively with IT and technical teams, with skills in stakeholder facilitation and structured problem-solving.
Nice to have - Lean/Six Sigma Green or Black Belt, BPM, Agile/Scrum, or equivalent certification. - Change-management certification.
Benefits and work setup - Remote work with occasional travel to company offices or other locations as needed. - Annual bonus and equity incentives, with pay determined by experience and internal equity. - Generous vacation time and observed public holidays, volunteer days, long-term incentive and employee stock purchase plans, wellbeing benefits, fitness reimbursement, tuition sponsorship, and professional development support. - Benefits vary by region and country.