Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in the U.S., have licensed our products in the US and international markets, and have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.

Our science and technology make us unique, but it is our team members that set us apart; they are the engine that fuels Tris’ passion and innovation. Tris colleagues understand the criticality of operating a successful business and take pride in the company’s success. But of equal importance to each member of the team is how we interact with one another on a daily basis. We believe in each other and we believe in respectful, open and honest communications to help support individual and team success.

We have a position in Monmouth Junction, NJ for an Information Technology Head/Chief Information Officer to join our small, but experienced, in-house IT team. Title commensurate with experience.

The Head of IT is responsible for developing and implementing organization’s IT strategy aligned with company goals. Incumbent oversees all IT projects, IT operations, Data Privacy and overall Information Security, and also is responsible for managing related budgets, IT resources and overall priorities.

She/he oversees day-to-day IT operations and business application system and provides leadership in management of IT Applications and Infrastructure, IT helpdesk services and related processes etc. supporting business units/functions throughout the organization.

The Head of IT is accountable for adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

ESSENTIAL FUNCTIONS

• Leads IT strategic and operational planning to achieve business goals by fostering innovation, prioritizing IT initiatives and coordinating evaluation, deployment and management of current and future IT systems across organization; Develops and maintains appropriate IT organization structure to support business needs; Develops recommendations for systems/functions (ranging from Business Applications, Data Security and Privacy, Data Analytics and overall infrastructure)
• Collaborates closely and partners with Senior Leadership, department heads related to business IT applications, solutions, opportunities and strategy
• Responsible for coherent and consistent IT application landscape based on solid IT strategy and IT solution architecture for various business functional domains (i.e., Production, Marketing & Sales, Clinical, R&D Finance, Quality, etc.)
• Assures IT Technology Strategy and IT business application strategy are aligned and assures IT solutions are driving appropriate business outcome; Partners and leads together with business successful implementation and operations of all IT applications
• Oversees data integrity, security and protection of information assets including Business Resumption planning
• Assures IT services (Application and Infrastructure) operational availability at industry standard level
• Develops, manages and tracks IT budget, IT procurement and major capital equipment and department expenditures
• Proactively Communicates to senior leadership on IT portfolio, priorities, projects and progress, issues and roadblocks
• Ensures compliance with all current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and Occupational Health and Safety Administration (OSHA) regulations, as well as all applicable company compliance guidelines, standards and objectives; Ensures all systems and services are in compliance with GxP, FDA, Data Privacy regulation, guidelines and standards
• Leads by example, manage and continuously develop IT business application and IT operation team including, but not limited to: employee training and development plans, and create and maintain continuous improvement culture

Special knowledge or skills needed and/or licenses or certificates required:

• Bachelors degree and minimum 15 years IT experience in positions of increasing strategic and technical responsibility in the pharmaceutical, biotechnology or other highly regulated industry under GxP and other pharma compliance regulations (minimum 6 of those years managing direct and/or indirect reports).

• Deep understanding of various business functions (i.e., Finance, Manufacturing, Quality, Commercial, Regulatory, Medical, etc.) including related business applications business data and technologies

• Experience leading IT operational and strategic initiatives in a highly regulated environment

• Knowledge and experience with 21 CFR Part 11 and FDA guidance documents in managing application/system changes in accordance with computer system validation

• Experience implementing and leading IT change management and governance process, owning deviations and change control in a regulated environment

• Department and people management leadership experience

• Ability to influence without direct authority

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-hybrid