Quality Management Director
5 days ago
Biotech Healthcare is seeking a highly skilled Quality Management Director to lead our quality management system and ensure compliance with regulatory requirements.
The successful candidate will have a strong understanding of GMP, GDP, ISO 13485, and FDA regulations, as well as experience in managing quality projects, conducting internal audits, and performing gap analyses.
A key objective of this position is to design, implement, and enhance organizational work practices that align with quality management principles. This includes establishing a culture of continuous improvement, compliance, and operational excellence within the organization.
As a Quality Management Director, you will be responsible for overseeing the approval process for Site Master Files, Validation Master Plans, Quality Manuals, and stability summary reports. You will also ensure procedural compliance in handling Change Control Notices (CCN), deviations, market complaints, Out-of-Specification (OOS) issues, CAPA, and IPQA non-conformances.
An estimated salary for this position is between $120,000 to $150,000 per year, depending on qualifications and experience.
This role involves:
- Designing, implementing, and maintaining a robust Quality Management System (QMS) framework
- Authorizing and reviewing SOPs, master documents, and quality protocols
- Overseeing the approval process for documentation
- Conducting internal audits and self-inspections
- Investigating quality-related issues and implementing corrective actions
We are looking for a highly skilled professional who can lead cross-functional teams and drive quality improvement projects. If you have a strong track record of success in quality management and leadership, we encourage you to apply.
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