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Associate Director, QC Stability

2 months ago

Oxford, United Kingdom Hyper Recruitment Solutions Full time

We are currently looking for an Associate Director, QC Stability to join a leading Biopharmaceutical company based in the Oxford. As the Associate Director, QC Stability you will be responsible for setting up and maintaining a compliant stability program and regulatory submissions in both clinical and commercial settings.


KEY DUTIES AND RESPONSIBILITIES:


Your duties as the Associate Director, QC Stability will be varied however the key duties and responsibilities are as follows:


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.


ROLE REQUIREMENTS:


To be successful in your application to this exciting opportunity as the Associate Director, QC Stability we are looking to identify the following on your profile and past history:


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.


Key Words: Associate Director | QC Stability | Biopharmaceutical | Stability program | Regulatory submissions | Clinical | Commercial | GLP | GMP | Laboratory testing | Continuous improvement | Quality Control | QC |