This is a new Trackwise Digital (Cloud) implementation. The candidate must have some Trackwise Digital experience versus on prem Trackwise. This is a senior role looking for 10+ years of experience. The candidate will be the Systems Owner and requires strong comm skills working closely with QC, QA and manufacturing teams working on workflows and automations.
IT Principal Quality Systems Analyst (Trackwise)
Description
The IT Principal Quality System Analyst (Trackwise) is responsible for owning the IT Quality Management System (QMS) Technologies and Support. The primary role for this individual will be ownership of the technical QMS solutions and provide technical support to the Quality organization. Specific area of concentration includes but not limited to Documentation Management, Deviation, Investigation, CAPA, Change Control etc. This role will partner with the business and vendor(s) to define functional and integration requirements for the QMS and with other strategic technologies. This individual will play a key role in the design/development, deployment, and maintenance/support of the QMS validated state, including modifications due to upgrades and software releases.
Key Responsibilities/Essential Functions • Strong understanding of QMS Technologies specifically TrackWise Digital implementation and maintenance. • QMS vendor management experience while implementing the solution and/or new functionality as well as migrating legacy data into the QMS • Develop/maintain QMS Data Analytics and Dashboards • Knowledge of integrating the QMS with other strategic technologies such as ERP, LIMS, LMS etc. • Gather, develop, clarify, and document functional/user business requirements • Transform the users' requirements into functional requirements • Collaborate with Project Managers on issues, concerns, schedules of deliveries and completion estimates • Experience working in GxP-validated environment and have created and executed validation documents • Translate objectives into work plans and guide execution. Leverage data for analysis and recommendations for solutions where possible. Develop and manages operational initiatives to deliver tactical results. Provide management updates on risks and opportunities to ensure desired results are achieved. • Maintain and demonstrate knowledge of current relevant US and global regulatory requirements/guidelines (e.g. cGMP, FDA, USP/EP/JP+). Update internal procedures to ensure compliance. Extensive knowledge of industry practices for assigned area including specialized functions/technology, concepts, techniques, and standards. Serve as area expert in field within the organization, also leverage other experienced staff SMEs. Effectively communicate and present results and recommendations across discipline. • Liaise with departments at various management levels regarding operations and projects. Provide direction to team, act on issues, make good and timely decisions that keep the organization moving forward, monitor, and report on progress. • Align own work plans and priorities with those of other units. Balance the need for adequate planning with the need for action. Create realistic timelines with steps outlined in the right sequence. Anticipate and minimize bottlenecks or delays. • Accept needed change despite the uncertainty it brings. Constructively deal with problems that do not have clear solutions or outcomes. Remain calm and productive during transitions or changing circumstances. Work to clarify situations where information, instructions, or objectives are ambiguous. Address problems without clear solutions, making substantial progress. • Actively promote safety rules and awareness. Always demonstrate good safety practices including the appropriate use of protective equipment. Report and takes initiative to correct safety & environmental hazards. • Work individually and as a team with quality and attention to detail. Independent positive leader with strong communication and solid interpersonal skills both oral and written. Effectively and efficiently participate in assigned tasks in a quality manner. • Demonstrate & adhere to Lantheus corporate Values. Actively demonstrate quality, accountability, customer service, efficiency, collaboration, and safety, as well as appropriate workplace behaviors and professionalism, including respect, flexibility, and a positive attitude toward work and others.
Skills and Experience and Education • BA/BS degree in Information Technology or Computer Science with 5+ years progressive experience in data integration • Experience in the following areas preferred: Quality Systems & Document Management, Quality Assurance, Computer Systems Validation, GxP, Validated Change Control and Product Life Cycle Management. • Understanding of Computer Systems Validation and the full Software Life Cycle management • Strong written and verbal communication skills. • Strong collaboration skills with the ability to work in a team dynamic across multiple functional organizations. • Experience in the life science industry or like industry essential • Demonstrated analytical, troubleshooting, and problem-solving skills.
Other Requirements • Flexibility with scheduling requirements for support typically Mon-Fri, but may include evenings, weekends, shifts, and/or holidays. Some non-routine overnight travel based on business need travel may be required. • Current SME-level knowledge of modern industry best practices, implementation and procedures for Quality Management Technologies and applicable regulatory requirements. SME-level knowledge of and previous experience with relevant Quality Management System software, validation, processes, budget planning and cost containment, and project planning/execution preferred.