Senior Manager, IT Applications - Laboratory Informatics

Responsibilities Manage a team supporting and maintaining IT Applications (e.g., Empower CDS, SDMS) including performance management, mentoring, coaching, and staff development. Collaborate with peer managers to align shared best practices and coordinate delivery across the IOPS IT Applications function. Partner with global counterparts to support and maintain globally deployed QC systems in a consistent and compliant manner. Drive audit readiness; serve as a key point of contact during FDA inspections and internal audits to ensure systems, audit trails, and documentation are inspection‑ready. Ensure applications are maintained in a compliant, validated state with focus on data integrity and 21 CFR Part 11; proactively identify and resolve data integrity/compliance issues per applicable DI principles, SOPs, and policies. Maintain accurate validated system documentation (e.g., User/Design/Configuration Specifications, Test Plans). Manage vendor relationships (performance, contract adherence, regulatory/business compliance). Implement operational rigor using metrics and controls; drive continuous improvement to enhance workflows, system reliability, and team efficiency. Qualifications & Skills Recognize and uphold ALCOA+ principles and data integrity; demonstrate integrity and “right first time.” Passion for quality; proven ability to support applications in a highly regulated environment. Knowledge of cGMP, GAMP, 21 CFR Part 11, and Annex 11. Knowledge of Regulatory Asset Manager Systems (advantageous). Excellent written and oral communication skills; strong customer‑facing skills across cross‑department levels. Bachelor’s degree in IT, Science/Engineering, Computer Science, or related field. Manager: 7+ years’ experience; 3+ years managing teams. Senior Manager: 8+ years’ experience; 4+ years managing teams. GMP Laboratory/IT setting preferred. May consider relevant experience in lieu of education. Benefits (U.S.) health and wellness programs, fitness centers, 401(k) match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (for eligible employees). Application Instructions Apply now. #J-18808-Ljbffr Scorpion Therapeutics