Manager

• As a Validation Manager (m/f/d), you will play a key role in advancing our innovative drug development program
• You will take ownership of all validation activities in the development of our products
• Working closely with multidisciplinary teams and external partners, you will ensure our processes and products meet the highest standards of quality, safety, and regulatory compliance
• Reporting to the Senior Director of Quality, the Validation Manager will have responsibility to develop and manage all validation activities under the Quality Management System
• Provide expert advice on the validation strategy for development programs
• Develop and maintain the Validation Master Plan (VMP)
• Develop systems, processes, tools and templates for the conduct of qualification and validation activities
• Work cross functionally to develop qualification and validation protocols in accordance with the requirements of the VMP
• Review and approve qualification and validation reports
• Project Management of validation activities
• Initiate and manage deviations, changes and risk assessments in the conduct of validation activities
• Quality oversight of the stability program
• Quality oversight and support for technical transfer activities
• Support the ongoing continuous improvement of the company’s QMS in compliance with applicable GxP requirements and regulatory guidelines
• Leading Quality Excellence: Lead by example in promoting and facilitating a quality culture
• Work cross functionally to provide quality oversight, support and expertise in the conduct of quality related activities across development projects, employing Quality by Design (QbD) principles
• Provide training to staff on quality topics
• Support the conduct of quality investigations and initiatives
• Prepare, manage and present materials for Quality Management Review

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