The Validation Manager utilizes strong leadership skills and extensive knowledge of current validation standards to effectively manage a team of VE with applying regulatory guidance and industry standards to ensure a risk-based validation approach is being utilized to generate protocols for both manufacturing processes and equipment. Additionally, drives continuous improvement with respect to a risk-based validation approach.
The role involves liaison with Quality Engineers, Value Stream Engineers, Product Engineers, External Customers, Regulatory and Project Teams to provide expert advice on matters relating to current validation standards.
Role determines direction, priorities and assigns resources to ensure the company priorities are met.
Role Responsibilities

• Provide leadership, direction, and support to improvement programs using Six Sigma
• Support and guidance to VE with regards to regulatory guidance and industry standards to ensure a risk-based validation approach.
• Maintain the documentation required for their personal EPR process, including training record and complete regular reviews for direct reports and input into MTR processes.
• Ensure VE personnel are appraised, have regular access to 1:1 session, have clear job descriptions of routine accountabilities plus additional SMART objectives as well as development and training plans as appropriate.
• Responsible for reviewing and approving protocols, investigations and collaborating with key stakeholders and customers to ensure validation activities are completed in a timely manner.
• Interact with Customers, through technical interfaces and audits. Be available to discuss validation concerns with Customers to present Kindeva position.
• Participate in Inspection readiness activities and Regulatory Inspections.
• Participate in New Product Introduction (NPI) activities as they relate to validation activities.
• Review and approval of SOPs, Protocols, Technical Reports, Deviations, CAPAs, Change Controls/MOC’s, and other GMP documentation.
• Responsible for the closure of audit actions for the department

Basic Qualifications

• Bachelors degree or higher in an engineering or science discipline
• Minimum 10 years’ validation experience within a pharmaceutical or medical device industry
• Minimum 3 years’ Supervisory experience or experience in leading a team