Global Validation Manager

Global Validation Manager

Datwyler

Alken, Belgium

As a Global Validation Manager you manage the validation and qualification approach across all our manufacturing facilities, ensuring that our processes align with industry regulations and standards.

Key Responsibilities

• Formulate and implement a global validation strategy: develop a comprehensive approach to validation and qualification that meets GMP (Good Manufacturing Practices) regulations, industry standards and customer expectations. Ensure that the strategy is aligned with corporate objectives and regulatory requirements;
• Support the development and improvement of global procedures and specific instructions for each validation/qualification subject. Collaborate on establishing validation standards for non-standard technologies. Develop templates for validation plans, protocols, and reports;
• Issue an aligned global Master-Validation-Plan and establish a report out on the execution for all stakeholders on regular base;
• Stay informed about regulatory requirements and industry best practices : monitor changes and keep our validation strategy current and compliant with evolving standards;
• Review and approve validation protocols, reports, and related documentation to ensure accuracy, completeness, and compliance with regulatory requirements;
• Provide guidance and support to internal teams on validation and qualification matters. Develop training programs to ensure awareness and understanding of validation principles and requirements;
• Collaborate with cross-functional teams to conduct risk management related to validation and qualification activities. Develop strategies to mitigate risks and ensure process robustness;
• Develop and maintain the global process control strategy in collaboration with global process engineering and relevant process owners;
• Draft project validation plans for impactful projects, to be utilized by the validation team in protocol and report writing;
• Change Control Management: Establish and maintain robust change control processes related to validation activities. Ensure that changes to equipment, processes, or facilities are properly evaluated and validated to maintain product quality and compliance;
• Data Integrity Assurance: Implement measures to ensure the integrity of validation data and documentation. Develop and maintain documentation standards for validation protocols, reports, and related documents;
• Work closely with Quality Assurance, Regulatory Affairs, Engineering, and Manufacturing teams to ensure alignment of validation activities with business objectives and regulatory requirements.

What We’re Looking For

• Bachelor’s degree in Engineering, Chemistry, Pharmacy, or related field. Advanced degree preferred;
• Minimum of 5 years of experience in validation within a GMP regulated environment, preferably in the pharmaceutical or related industry;
• Strong understanding of GMP regulations and industry standards related to validation and qualification (e.g., FDA, EMA, ICH);
• Experience in developing and implementing validation strategies across multiple sites or regions;
• Excellent project management skills with the ability to manage multiple validation projects simultaneously;
• Strong analytical and problem-solving skills, with a keen attention to detail;
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams;
• Experience with validation software and tools is a plus.