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Associate Director/Director of Information Systems

Summit Biosciences Inc.

This is a Full-time position in Lexington, KY posted June 9, 2021.

Summit Biosciences is a fast growing leader in the field of Intranasal Pharmaceuticals.

At Summit Biosciences, we aim to provide and promote an environment of continuous learning and improvement, which leads to and harnesses innovation.

We offer fantastic perks & benefits such as strong compensation with bonus program, medical/dental/vision/life/disability insurance, 401k + company match, holidays off, PTO, a family like culture, and much more!

The Associate Director /Director of Information Systems is responsible for the overall operation of the Information Systems department including implementation of electronic systems to help streamline work, reduce costs and maintain quality. This position is responsible for leading a team to identify, implement and manage computer systems for all functional areas in an FDA regulated pharmaceutical manufacturing organization.

?Essential Duties: 
Manage the day-to-day operations of the Information Systems department in a high-growth, fast-paced, dynamic work environment while ensuring compliance with FDA, EU, and DEA regulations  Lead the evaluation of new electronic systems to identify total cost of ownership and benefits Write SOPs, programs, and protocols necessary for operations Lead validation activities related to computerized systems and contribute as a member to the manufacturing plant validation team Ensure security and data integrity of the IT infrastructure and operations Develop and implement disaster recovery programs Lead or assist in troubleshooting of networks and computer driven laboratory instruments and automated manufacturing equipment and systems Manage all stages of IS projects with minimal direction including planning, implementing, reporting progress and solving challenges Maintain and evaluate hardware and software needs Develop training programs for new and existing systems Manage changes and change control documentation related to IS related projects Manage relationships with external resources and vendors Recruit, train and manage direct reports Assist with DEA security and control activities Develop budgets for the Information Systems department

Preferred Knowledge, Skills and Abilities: 
Ability to plan and manage well in order to deliver high quality results on time Extensive technical experience managing the IS function for an organization including experience with ERP systems, and other electronic systems Demonstrated knowledge of modern Information Systems and new technology, preferably in a regulated manufacturing environment Understanding of current Good Manufacturing Practices (cGMPs) Proven team player with well-developed interpersonal, organizational and communication skills, including written documentation and presentation skills Ability to change priorities in response to company demands while continuing to deliver results Experience in computerized system validation in the pharmaceutical industry is a plus

Desired Skills and Experience
BS in Computer Science, Information Systems or related field 7 years of applicable experience with at least 4 years in a leadership role 4 years of experience in an FDA regulated GMP environment Excellent technical writing, project management and exceptional organizational skills Good interpersonal skills and the ability to work well in a team environment Enthusiasm for building a company with outstanding work ethic; must be able to perform in a fast-paced multiproduct environment Able to shift the priorities of the team quickly while continuing to deliver exceptional work quality Enthusiasm for working in teams and collaborating with both internal and external colleagues Proven ability to train staff on complex analytical equipment and processes