Are you a seasoned candidate in Quality Assurance (PVQA) with a passion for compliance, risk management, and strategic leadership
Our client, a leading innovator in the life sciences sector, is seeking a seasoned Quality Assurance expert to spearhead their global GxP compliance framework. In this pivotal role, you will serve as the definitive Subject Matter Expert (SME) for GCP, GLP, and GVP standards, ensuring that the organization's global operations are not only compliant but best-in-class.
Key Responsibilities:
- Perform expert reviews of GxP related SOPs to identify gaps and ensure global consistency.
- Coordinate and lead the response for regulatory audits, providing strategic input for documentation and follow-up actions.
- Analyze quality trends and metrics to drive continuous improvement initiatives across the QMS.
- Use audit data to sharpen the QMS and mentor teams on GxP best practices.
- Partner with cross-functional teams to integrate new regulatory requirements into existing workflows.
- Evaluate quality metrics and audit findings to identify trends, driving a culture of continuous improvement within the QMS.
- Develop and deliver specialized training programs to enhance inspection readiness across various business units.
What We're Looking For:
- A degree in Life Sciences, Pharmacy, or a related field is required.
- A minimum of 8+ years of experience within GxP Quality Assurance or Clinical Quality Management in the pharmaceutical or biotech sector.
- Comprehensive knowledge of global regulatory frameworks, including experience managing complex inspections.
- Proven ability to influence stakeholders within a global matrix environment.
How to Apply:
- Interested applicants may apply by sending in your updated rsum (in MS Word format) to my email or apply directly:
- Consultant: Tan Weixiang
- EA personnel reg. no.- R1658660
- EA License No. 17C8502
