Global Validation Manager

Target of the position

Manage the validation and qualification approach across all our manufacturing facilities, ensuring that our processes align with industry regulations and standards.

Duties and 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.
• Stay informed about regulatory requirements and industry best practices : monitor changes and keep our validation strategy current and compliant with evolving standards.
• 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.
• 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.
• 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.
• 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.

Knowledge and requirements

• 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.

Interaction and communication

• Lead project teams.
• Collaborate with the Global Process Engineering team on validation and qualification procedures and documents.
• Coordinate with the Head of Global Quality Services on daily work activities.
• Present project progress to management.
• Engage with DIT, engineering, operations, and QA/QC teams to advise and persuade.
• Communicate with customers regarding relevant quality topics, including complaints and deviations, providing advice and advocacy.
• No direct reports - works with ad hoc team members as needed.