Quality Compliance Manager
2 days ago
CK Group is seeking a highly skilled Quality Compliance Manager to join our team in Cambridge. As a key member of our organization, you will be responsible for ensuring the highest standards of quality and compliance across all aspects of our business.
Key Responsibilities:
- Maintain and improve our Quality Management System (QMS) to ensure compliance with global regulatory standards and guidelines.
- Develop and implement Standard Operating Procedures (SOPs) and training programs to ensure effective quality and compliance practices.
- Lead the audit program, covering all research and development activities, from preclinical to clinical and CMC.
- Review and approve internal and external GxP documentation, including protocols, investigator brochures, and informed consent forms.
- Identify and implement process improvements to enhance quality and compliance.
Requirements:
- Relevant life science degree.
- Deep understanding of global regulatory and GxP compliance standards.
- Extensive experience in a regulatory function, such as clinical research or CMC, in an industrial setting.
- Experience hosting regulatory inspections and QMS management is highly desirable.
- Excellent written and oral communication skills, with the ability to interact effectively with colleagues.
What We Offer:
Competitive salary range of £70,000-£80,000, plus good benefits.
Hybrid working arrangement, with a location in Cambridge.
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