Quality Assurance Manager with Regulatory Expertise
7 days ago
About the Role
Biotech Healthcare is seeking a highly skilled Quality Assurance Manager to lead our quality management initiatives and ensure compliance with regulatory requirements. This key role involves designing, implementing, and enhancing organizational work practices that align with quality management principles.
Key Responsibilities
- Develop and maintain a robust Quality Management System (QMS) framework in line with regulatory requirements and industry standards.
- Autorize and review SOPs, master documents, and quality protocols, ensuring comprehensive compliance across all operational processes.
Compliance & Documentation
- Oversee the approval process for Site Master Files, Validation Master Plans, Quality Manuals, and stability summary reports.
- Ensure procedural compliance in handling Change Control Notices (CCN), deviations, market complaints, Out-of-Specification (OOS) issues, CAPA, and IPQA non-conformances.
Audit & Risk Management
- Lead internal audits and self-inspections to assess compliance with quality standards and identify areas for improvement.
- Investigate quality-related issues, conduct root cause analysis, and implement corrective and preventive actions (CAPA).
Project Leadership
- Drive quality improvement projects and initiatives, collaborating with multidisciplinary teams to enhance operational efficiency and compliance.
- Act as the Management Representative (MR) for quality reviews, planning and conducting Management Review Meetings (MRM), and following up on action items.
Salary: $120,000 - $150,000 per annum
This salary estimate reflects the level of expertise required for this role, taking into account factors such as location, industry standards, and the company's size and complexity.
Bachelor's degree in a relevant field such as quality assurance, engineering, or science, combined with 10-12 years of experience in Quality Assurance or related fields, preferably within the Medical Device Industry.
Strong understanding of regulatory requirements, including FDA, ISO 13485, GMP, and GDP.
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