Regulatory Compliance Manager
1 day ago
About the Job:
The Regulatory Compliance Manager plays a critical role in ensuring all pharmaceutical products manufactured or distributed by the company comply with global and local regulatory requirements, company standards, and customer expectations.
Reporting to the Director of Quality, this role is responsible for developing, implementing, and maintaining the Quality Management System (QMS) in compliance with GMP, regulatory requirements, and company policies. The Regulatory Compliance Manager will oversee the management of SOPs, Work Instructions, and other quality-related documentation, as well as lead internal audits and participate in external audits and regulatory inspections.
This role requires strong leadership and communication skills, with the ability to handle multiple tasks and prioritize effectively. The Regulatory Compliance Manager will also be responsible for ensuring all quality control activities are documented and carried out in accordance with established procedures, collaborating with the Qualified Person (QP) to ensure batch documentation is reviewed, and products are released in compliance with regulatory requirements and company standards.
Additionally, the Regulatory Compliance Manager will promote a culture of continuous improvement by identifying areas for improvement and implementing effective solutions, using quality metrics and data analysis to drive process improvements and enhance product quality.
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