Senior Validation Leader

Validation Strategist

Compliance Group Inc. is seeking a highly skilled Validation Strategist to lead our validation efforts.

Key Responsibilities :

• Develop and implement thorough validation strategies, processes to ensure quality and reliability of products throughout the development lifecycle.
• Collaborate with cross-functional teams including development, assurance, etc. to define validation requirements and priorities.
• Establish validation plans, protocols, and procedures in compliance with regulatory standards (e.g., FDA, ISO, MHRA) and industry best practices.
• Oversee execution of validation activities, ensuring thoroughness and accuracy, including IQ / OQ / PQ, software validation, process validation.
• Perform risk assessments and develop risk mitigation strategies to address potential product risks related to validation along with key stakeholders.
• Drive continuous improvement initiatives to enhance validation processes, streamline workflows, increase efficiency.
• Manage relationships with external vendors and contractors as needed for validation testing services.
• Ensure end-to-end documentation and traceability of validation activities, including validation plans, test plans, test protocols, test reports, validation reports, trace matrix.
• Provide regular updates and reports on validation activities to Quality Assurance, status to senior management and stakeholders, raise risks proactively.