Regulatory Affairs and Quality Manager
6 days ago
Job Title: Regulatory Affairs and Quality Manager
About the Role:
We are seeking a highly experienced Quality and Compliance Manager to join our team at CK Group. 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 implement a robust Quality Management System (QMS) to ensure compliance with all relevant regulatory guidelines and standards.
- Oversee the development and implementation of Standard Operating Procedures (SOPs) and training programs to ensure effective quality and compliance practices.
- Identify and implement process improvements to enhance efficiency and effectiveness.
- Collaborate with cross-functional teams to ensure quality and compliance are integrated into all aspects of our business.
- Host and manage regulatory inspections and audits to ensure compliance with regulatory requirements.
Requirements:
- Proven experience in a regulatory function, preferably in a clinical research or CMC setting.
- Extensive knowledge of global regulatory and GxP compliance standards.
- Strong leadership and communication skills to effectively manage and train teams.
- Ability to analyze complex data and implement process improvements.
What We Offer:
CK Group is a leading provider of specialized services to the life sciences industry. We offer a dynamic and supportive work environment, competitive compensation and benefits package, and opportunities for professional growth and development.
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