Validation Manager - #1718296

Overall responsibility for delivering all validation requirements related to the Capacity Expansion project. This includes creating the Validation Masterplan for the project, in line with local and global business needs, aligned with the on-site Validation team.

Responsibilities:

1. Deliver all scheduled activities required on each day through effective and concise communication with team members, and the ability to listen and discuss ideas in an open and professional manner.


2. Provide support and mentorship to Validation staff and other team members on professional or technical/scientific topics.


3. Responsible for writing and reviewing all validation deliverables, SOPs, and related documentation.


4. Provide clear procedural and documentation training and set expectations to staff, emphasizing quality and efficiency to deliver data (right first time) for validation projects.


5. Develop training materials and deliver training/mentorship on relevant techniques and procedures, providing expert advice on training requirements. Ensure staff are trained before scheduled activities.


6. Review the work of others for accuracy, timeliness, completeness, and soundness of technical judgment.


7. Implement action plans to solve project or technical problems as they occur.


8. Independently review scientific content, accuracy, and study validity in validation deliverables.


9. Identify and implement process changes to streamline current practices and deliver cost-effective measures/lean concepts.


10. Drive process improvement initiatives and develop guidance on best practices when required.


11. Ensure staff compliance with policies and regulatory guidelines through completed training, readings, or other modes.


12. Inform management of staff, procedural, or site problems affecting data integrity; take ownership of corrective actions independently.


13. Perform leadership activities including staff recruitment, onboarding, retention, performance evaluation, and disciplinary actions.


14. Develop expertise in a key process/area within the department.

Requirements:

1. Bachelor’s degree in science, engineering, or related field + 5 years of relevant experience OR master’s degree + 3 years of relevant experience.


2. Previous supervisory and management experience.


3. Knowledge of regulatory agency requirements/guidelines, e.g., EU GMPs, FDA, Data Integrity.


4. Experience with full responsibility for a site or project validation requirements.


5. Experience working within a Quality Management System.