Trackwise Validation Lead

***** CONTRACT ROLE *****

***** TRACKWISE EXPERIENCE IS MANDATORY *****

We are seeking a highly skilled and experienced TrackWise Validation Lead to join our Quality Assurance team. The ideal candidate will be responsible for leading the validation efforts for the TrackWise system, ensuring compliance with regulatory requirements and company standards. This role involves coordinating with cross-functional teams, developing validation strategies, and overseeing the execution of validation activities.

Key Responsibilities:

• Manage and lead

  TrackWise validation projects

  , including planning, execution, and documentation.
• Create comprehensive validation plans, protocols, and reports in accordance with regulatory guidelines and industry best practices.
• Conduct risk assessments to identify potential issues and develop mitigation strategies.
• Collaborate with IT, Quality Assurance, and other departments to ensure successful validation of the TrackWise system.
• Provide training and support to team members and end-users on validation processes and TrackWise functionalities.
• Ensure all validation activities comply with FDA and other relevant regulatory requirements.
• Identify opportunities for process improvements and implement best practices in validation activities.
• Maintain accurate and detailed documentation of all validation activities and ensure timely completion of validation deliverables.

Qualifications:

• Strong understanding of regulatory requirements (FDA, EMA, GxP) and industry standards for validation.

• Must have TrackWise On Prem testing experience.

• Excellent project management, communication, and problem-solving skills.
• Relevant certifications in validation or quality assurance are a plus.

Preferred Attributes:

• Detail-oriented with strong analytical skills.
• Ability to work independently and as part of a team.
• Proactive and able to manage multiple projects and team members simultaneously.
• Strong leadership and mentoring abilities.