Senior Director of Quality and Compliance

2 weeks ago


Oxford, Oxfordshire, United Kingdom Hyper Recruitment Solutions Full time

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

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