The QA Systems Manager leads global implementation, migration, validation, and management of electronic Quality Management Systems (eQMS) and pharmaceutical computerized systems across UK and US sites.
They act as a Subject Matter Expert on platforms like MasterControl, ensuring compliance with GMP, Annex 11, MHRA, and other regulations.
Key responsibilities include managing system projects, supporting deployment and training, maintaining validation documentation, and promoting continuous improvement.
They ensure audit readiness, support regulatory inspections, and oversee data integrity and archiving.
The role requires experience with GxP systems, CSV activities, and eQMS platforms, strong project management skills, and the ability to communicate technical concepts effectively.
Travel is minimal, with approximately 10% of time expected for trips. A background in life sciences or related fields, with at least 5 years of pharmaceutical industry experience, is preferred.