Senior Manager, Quality Control Stability

4 weeks ago


Oxford, Oxfordshire, United Kingdom Hyper Recruitment Solutions Full time

We are seeking a highly skilled Senior Manager, Quality Control Stability to lead our stability program and regulatory submissions in both clinical and commercial settings.

Key Responsibilities:

1. Oversee routine and non-routine stability studies, ensuring all data reports and documentation to support regulatory submissions are available on schedule.

2. Manage and maintain a compliant stability program, including sample management, identifying stability studies, authoring stability protocols and reports, and maintaining trending of all stability activities.

3. Provide technical expertise for laboratory investigations, troubleshooting assays, and ensuring acceptably low invalid rates.

4. Lead the QC Stability team, including recruitment, leadership, and direction, as well as managing external vendors and contract testing facilities.

Requirements:

1. Relevant degree in Chemistry, Biochemistry, Microbiology, or a related science.

2. Extensive industry experience in a GLP/GMP-regulated environment, with a focus on laboratory-based testing and management.

3. A working knowledge and practical experience with stability testing, regulatory submissions, and continuous improvement processes.



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