Quality Systems Manager

Job Summary

A company is looking for a Manager, Quality Systems.

Key Responsibilities:

• Manage and maintain a compliant Document Control System, overseeing change control processes and archiving activities
• Oversee the training program, including reporting non-compliance and reviewing curricula for appropriateness
• Manage processing of QMS items for Change Control, Deviations, and CAPAs, generating Quality System metrics as needed

Required Qualifications:

• Bachelor's degree in life sciences or related field with a minimum of 5 years in a GMP regulated industry
• Experience with monoclonal antibodies is preferred
• In-depth knowledge of GMP regulations and quality systems
• Experience using Veeva electronic quality management systems (eQMS) is required
• Ability to work independently and within project teams, supporting multiple projects simultaneously