It Manager - Quality Management Systems

IT Manager - Quality Management Systems

Primary Location: Wilmington, MA / Remote

Job Function: Information Technology

Job Type:Full-time

Job Summary

Reporting to the Senior Director of Business Applications, the IT Manager - Quality Management Systems holds a pivotal role in our organization, overseeing the management, implementation, and support of all Quality applications. As the manager of our suite of business applications, this individual will ensure that software modules perform optimally, remain up-to-date, and maintain robust security measures. They will demonstrate a strategic and proactive approach, leveraging best practices to deploy new applications and processes company-wide while managing integrations between enterprise applications and other platforms.The successful candidate will have experience working within a regulated biotech/medical device environment and will be expected to interact with personnel across all levels and functional areas within the company. The position will encompass multiple tasks, including but not limited to maintaining / co-administering compliant GxP Quality Systems (Document Control, Training LMS, Change Control, CAPA, Deviations, Investigations, Risk Management, & Complaint Handling) in accordance with US and International guidelines and regulatory requirements.

This role will work closely with Viant's Quality Management Teams, GxP business stakeholders, and IT technical teams to ensure sustained compliance across Viant's QMS.

Duties & Responsibilities

Per the requirements of the position, the IT Manager - Quality Management Systemswill provide guidance, leadership, and direct input for the following tasks across the organization:

• Adhere to Viant's QMS Policies and procedures to ensure continued compliance.
• Partake and co-manage system improvements, which include performing configuration, testing, data migration, and additional tasks associated with transitioning into new enhanced eQMS systems.
• Manage implementation and day-to-day operations of all Quality System related software at all Viant manufacturing sites and design centers.
• Partner with the Quality Leadership Team in the selection of the most suitable Quality System software solutions.
• Lead and partner with site-level quality teams to implement and validate new and revised quality system software.
• In conjunction with QS IT Staff, develop and provide end-user support across all Viant sites; serve as an eQMS Subject Matter Expert (SME) and provide daily end-user support.

• Provide inspection readiness support during internal audits and regulatory inspections (remote/on-site, as needed).

• Partner with Quality Leadership to perform/facilitate Quality System software training.
• Ensure that applications meet business and systems goals, fulfill end-user requirements, and identify and resolve system issues.
• Collaborate with teams to define, implement, and execute an enterprise-wide system use strategy.
• Establish structures and processes to plan and manage the orderly implementation of change.
• Perform system and business process reviews to evaluate system utilization for maximum efficiency.
• Understand business reporting requirements and assist with report design and development.
• Develop and implement maintenance and upgrade schedules to keep applications updated.
• Analyze documentation and technical specifications of new applications to avoid conflicts with existing functionality.
• Track and report the status of all user change and enhancement requests for enterprise applications.
• Ensure software integrations meet functional requirements, system compliance, and interface specifications.
• Work with company leadership to ensure user access levels in all systems are role-appropriate.
• Providing technical expertise to maintain the technology roadmap for Viant's Business Applications.
• Maintain current Standard Operating Procedures (SOP) documentation.
• Performing any other responsibilities as required to support organizational goals and initiatives.

Minimum Qualifications

• 4-year Degree in Computer Science, related field of Study, or College Degree plus IT experience
• 6+ years related to eQMS work experience within a regulated industry environment.
• Strong working knowledge and familiarity with Quality System Software platforms
• Experience managing IT applications (5+ years minimum).
• Basic knowledge of medical device regulations (FDA, ISO 13485)
• Proficient with software validation processes
• Must be flexible, organized, detail-oriented, and able to handle multiple priorities in a fast-paced environment.
• Ultimate accountability for the accuracy of all in-scope data, including the execution of any data updates required to ensure accuracy when endorsed by leadership.
• Proficient with, or able to quickly become proficient with, a range of general and specialized applications, software, and hardware used in the organization.
• The ability to use independent judgment to identify the root cause of problems and develop solutions to resolve them.
• Passion for Customer Success and continuous improvement.
• Successful candidates have a balance of functional (business) and technical experience.
• Ability to travel 40% to domestic and some international facilities.
• Authorized to work in the United States

Preferred education, experience & skills:

• Direct medical device manufacturing experience preferred.

• Understand manufacturing processes and IT systems and possess strong root cause analysis skills to identify correlations and draw conclusions.
• Exceptional organization, time management, and communication skills.
• Good verbal and written communication and presentation skills to accurately document and report findings to a variety of audiences

Company Overview:

Viant is a fully integrated supplier of medical devices, offering molding, manufacturing, and assembly services. With approximately 6,000 employees across 25 manufacturing locations in North America, Europe, and Asia, Viant is committed to delivering innovative solutions in the medical device industry.This position is hybrid; you will be expected to work on-site at one of Viant's facilities in the United States and/or attend Company-sponsored in-person events from time to time.