Responsible for leading market expansion and growth for Validation Management within the North American life sciences portfolio
Provide thought leadership and strategic direction to field-facing teams, including the development and maintenance of relationships with executive leadership at manufacturing sites
Provide business and technical guidance to the product team to ensure new features and functionality address the unique challenges of qualifying physical assets and complex production processes
Develop strategy and messaging to drive customer adoption, moving the market from legacy document-centric workflows to data-centric digital validation
Coordinate resources across the entire customer lifecycle, from initial sales discovery through to successful delivery and long-term value realization
Serve as an industry evangelist by presenting at conferences, leading webinars, and authoring content for industry publications
Engage with technical communities of practice and manage relationships with partners
Partner with the sales and services organizations to ensure an exceptional end-to-end customer experience that reflects a deep understanding of the manufacturing environment
Requirements
5+ years of experience in life sciences validation, with a heavy focus on commissioning, qualification, and the validation of manufacturing equipment and production processes
Deep technical understanding of the validation lifecycle (Requirements, Design, Verification, Acceptance & Release) for facilities, utilities, and process equipment
Experience with risk-based qualification approaches and a strong working knowledge of industry standards such as ASTM E2500, ISPE Baseline Guides, and Annex 15
Proven ability to innovate across business processes and technology solutions, specifically moving organizations from document-centric to data-centric validation models.
Experience implementing or consulting on digital validation software, with a focus on streamlining field execution and managing the qualified state of physical assets
Ability to hold meaningful conversations with heads of engineering, heads of quality, and IT leaders regarding the strategic use of validation applications across the enterprise
Strong communication skills with the ability to act as a subject matter expert in front of large audiences and executive stakeholders
Bachelor’s degree in Engineering (Chemical, Mechanical, Bioengineering, Electrical, or related technical field)
Ability to travel for customer meetings and industry presentations up to 40%