Senior Manager, GCP Process Excellence

Process Strategy, Governance & Portfolio Leadership Establishes and evolves process governance frameworks, standards, and best practices to ensure consistency and scalability. Drives or consults on the identification and implementation of process related change management needs Drives maintenance of the Process Portal to ensure easy access to the end-to-end clinical trial-related process families Partners with Process SMEs and Operational Effectiveness to implement process revisions identified in effectiveness checks Partners with EAs to proactively identify learning gaps; seek out, identify, and drive process improvements with a focus on standardization Drives process inspection readiness Consulting on CAPAs/Quality Events related to clinical trial processes University Degree in Science and/or a relevant discipline. Minimum 8+ years experience with a biopharmaceutical company and/or CRO and a track record of success in global clinical development or related disciplines including: Experience in global clinical study/site management Ability to execute work independently and with minimal supervision Ability to respond to change with agility, resilience, innovation, and optimism, seeking solutions based on creative problem solving, lessons learned and well-reasoned risk taking