Platform Technical Lead - Trackwise

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