Validation Manager

at  Merck

Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That’s why we are always looking for curious minds that see themselves imagining the unimaginable with us.

THE ROLE

Oversee all aspects of the Validation Program to ensure that validation processes and procedures are in compliance with ISO9001; ISO13485; 21 CFR 600; IVDD 98/79/EC; IVDR 2017/746 and other appropriate regulations and standards. This includes site safety requirements and applicable GxP and Good Manufacturing Practices (GMP).

KEY RESPONSIBILITIES:

• Management and development of robust and compliant validation processes and procedures to include maintenance, development and execution of the site Validation Master Plan and Data Integrity Governance Plan.
• Provide support and leadership to ensure compliance with both software and hardware validation regulatory requirements including 21 CFR parts 11, Annex 15 (Eudralex), GAMP and other guidance documents, as appropriate to the business needs.
• Provide validation support, resource, guidance and expertise to projects on validation requirements, including the development of required Validation Plans, preparation and execution of validation impact assessments, system risk assessments, protocols and reports.
• Provide validation resource, guidance and expertise in support of regulatory submissions, failure investigations, CAPA’s and continuous improvement initiatives.
• Development of cross functional and collaborative relationships within the facility.
• Development of effective internal and external customer relationships to ensure quality and regulatory compliance for the business with respect to validation activities.
• Preparation of validation reports, data and Key Performance Indicators for presentation to senior management as required and as an input to Management Reviews.
• Develop leadership and operational capabilities of direct reports. Establish career development plans with identified training needs and develop goals and objectives that stretch individual abilities. Provide regular and constructive performance appraisal and discipline, where appropriate.