Bachelor's degree with over 10 years of experience in designing and developing solutions in Trackwise.

• Experience working in a GMP environment, 7+ years in an IT Systems Role.

• Expert knowledge of GMP Quality Management to include CAPA/Deviation, Lab Exception, Product Complaint, Audit, and Supplier Management.

• SDLC/GAMP, Business Analysis, and Enterprise Systems Management.

• General knowledge of GxP Quality Processes and Systems (GMP, GLP, GCP, GVP, GDP)

• Demonstrated experience leading teams in the implementation of Trackwise and QMS solutions, ensuring alignment with business objectives and compliance requirements.

• Comprehensive understanding of Quality Management processes, regulatory compliance, and industry standards.

• Certification in Trackwise or Equivalent Experience is required.

• Strong leadership skills with the ability to manage and mentor a team of analysts and developers.

• In-depth knowledge of Quality Management business processes within a regulated environment, including CAPA/Deviation, Lab Exception, Audit, Product Complaints, and Supplier Management

• Extensive knowledge of Trackwise and other QMS modules, with additional familiarity with ERP, SCM, and PLM systems.

• Exceptional oral and written communication skills, with the ability to conduct effective presentations, facilitate workshops, and negotiate with stakeholders.

• Excellent organizational and prioritization skills, capable of managing multiple projects and tasks in a dynamic environment.

• Proven ability to handle multiple responsibilities, including system configuration, coding, system testing, end-to-end testing, and production support.

• Experience in all phases of the project life cycle from analysis and design to implementation and testing, with a focus on business process improvement and optimization.

• Strong analytical and problem-solving skills, with the ability to translate business requirements into technical solutions.

• Strong team player with excellent collaboration skills, fostering a positive team environment.

• Strong Knowledge of SDLC, GAMP, and Computer Systems Validation in a GxP Environment

Platform Technical Lead - Trackwise