Senior Director of Quality and Compliance
2 weeks ago
About the Role
We are seeking a highly experienced Senior Director of Quality and Compliance to join our team at Hyper Recruitment Solutions. The successful candidate will be responsible for setting up and maintaining a compliant stability program and regulatory submissions in both clinical and commercial settings.
Key Responsibilities
- Oversee routine and non-routine stability studies, ensuring all data reports and documentation to support regulatory submissions are available on schedule.
- 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.
- Lead the QC Stability team, including recruitment, leadership, and direction, as well as managing external vendors and contract testing facilities.
- Ensure the team has the necessary skills and expertise to meet the requirements of the role.
Requirements
- Extensive industry experience in a GLP/GMP-regulated environment, with a focus on laboratory-based testing and management.
- A working knowledge and practical experience with stability testing, regulatory submissions, and continuous improvement processes.
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