WHAT YOU’LL DO

• Develop and manage the portfolio of Tech Ops IT projects. Align IT Manufacturing technology roadmap with Manufacturing strategy, information security, GxP compliance requirements and enterprise IT architecture.
• Comprehensive business understanding of Quality and Regulatory functions within a life sciences organization. Beneficial to have an understanding of other functions such as Clinical Operations, Biometrics, and Drug Safety.
• Deep understanding of the necessary activities required to drive IT compliance to support regulatory filing, regulatory inspection, and commercial launch.
• Knowledge of 21 CFR Part 11, Annex 11, data integrity, and CSV process and clear vision for establishing a validation service to GxP stakeholders.
• Significant experience implementing SaaS systems and other software solutions to support regulated life science business processes.
• Serve as a technical subject matter expert to the organization and customers, and mapping customer requirements to software capabilities of IT systems ensuring optimal technical implementation.
• Own the System Lifecycle Management of Manufacturing application systems and interfaces.
• Lead the development of Service Agreements, Maintenance Agreements, Operating level agreements to enable end to end IT support delivery.
• Lead the requirements collection, definition phase and the design of software solutions and provide necessary business context into technical design discussions while working within defined enterprise architecture in collaboration with internal stakeholders. 
• Document/diagram functional process flows to ensure optimization and synchronization of systems, including identifying/advising on best applications for specific business processes, including cloud-based systems.
• Facilitates use case/story boarding for new systems/software or enhancements related to ERP and other manufacturing systems and processes.
• Develop and establish departmental SOPs, qualification/validation protocols and reports with ongoing awareness to changes in business or regulatory.
• Provide technical leadership to project managers, business analysts and programmers working on application/data analytics project teams.
• Work with business owners to formulate and conduct training sessions and teaching materials for propagating enterprise applications knowledge throughout the organization as appropriate.
• Recommend, schedule, and perform software improvements, patches, upgrades, and/or purchases.

WHO YOU ARE

• Bachelor’s degree in IT, CS, Business Process Management or related discipline or equivalent number of years of work experience.
• Minimum 10 years direct IT experience in roles of increasing responsibility in project/program management, business analysis, or other delivery leadership roles within a life sciences IT organization and 5 years of IT leadership experience.
• Experience with GMP environment, computer system validation, change management, and discrepancy reporting
• Minimum of 5 years of working experience with SAP including hands on experience implementing SAP.
• Technical mastery and knowledge of the relevant industry.
• Strong understanding of concepts of and hands on experience in MES systems architecture, installation and version management.
• Experience on GxP applications (and good Documentation Practices) and working in SOX audited environments is a plus.
• Ability to support mission-critical business solutions.
• Experience designing and implementing Incident, Problem Change, Version, Release, Configuration, Continuity management for mission critical manufacturing systems at a scale.
• Track record working in a fast paced, highly iterative environment.
• Should be able to communicate complex solutions and value in business terms. Verbal communication skills are critical and ability to adapt and learn to changing business environment and domains is a must.
• Experience in Life Sciences is preferred.