Director Software Engineering-Life Sciences

Director Software Engineering-Life Sciences

Requirements

• 12+ years of software development experience.
• 8+ years of software engineering leadership, managing global teams and scaling regulatory-compliant SaaS platforms within Life Sciences.
• Proven expertise in building SaaS platforms for Labeling Compliance, Regulatory, Quality, or Safety within Life Sciences.
• Bachelor’s degree in Engineering, Computer Science, or a related field; advanced degree preferred.
• Expertise in architectural principles, large-scale systems, and cloud technologies.
• Strong ability to leverage metrics for decision-making and lead test-driven development across global teams.
• Proficiency in database design, optimization, and best practices.
• Advanced knowledge of Agile methodologies, project management tools, and global team leadership.
• Proficiency in programming languages such as .Net/C#, Java, JavaScript, SQL, and XML.
• Experience with code reviews, development best practices, and project management tools for tracking progress, budgets, and scope.
• Strong organization, time management, and change management abilities across multiple departments.
• Proven track record of mentoring teams, prioritizing projects, and managing complex initiatives.
• Excellent problem-solving skills, with experience troubleshooting and coordinating solutions for complex technical challenges.
• Effective communicator, capable of conveying technical concepts to senior leadership, customers, and cross-functional teams.

Responsibilities

• Define and execute the technical vision and strategy for our Labeling Compliance SaaS platform, ensuring compliance with FDA, EMA, GxP, 21 CFR Part 11, Annex 11, ISO 27001, and ISO 9001 standards.
• Drive Agile best practices to enable continuous business value delivery.
• Collaborate with Technology Operations to implement defined PDLC/SDLC processes and leverage DORA and Flow metrics for data-driven decisions.
• Establish and enforce architectural standards, providing strategic and daily management to drive efficient product development.
• Recruit, mentor, and scale a high-performing global engineering team specializing in regulated SaaS solutions.
• Foster innovation by integrating emerging technologies such as AI/ML, automation, and advanced cloud efficiencies.
• Work closely with Product Management, Compliance, and Regulatory teams to align technology strategies with business objectives.
• Oversee vendor selection, qualification, and third-party integrations, ensuring adherence to enterprise and architectural standards.
• Act as the primary technical advisor, providing architectural input and strategic guidance across functional areas.
• Lead research, design, and development efforts while contributing hands-on expertise in complex coding, system design, and data management.
• Manage comprehensive testing cycles, including system and user acceptance testing, to ensure high-quality business solutions.
• Oversee hiring, training, performance management, and cultivate a culture of continuous improvement, accountability, and innovation.
• Engage with stakeholders to provide alternative solutions during system outages, finalize requirements, and maintain open communication throughout development.
• Ensure staff have the necessary training and resources to take ownership and contribute innovative ideas to improve solutions and services.

Preferred Qualifications

No preferred qualifications provided.