Leading Quality Assurance Professional
5 days ago
STAQ Pharma, a leading pharmaceutical company in Denver, is seeking an experienced Quality Assurance Manager to oversee the implementation and management of our Quality Management System (QMS).
The successful candidate will lead regulatory inspections, customer audits, and supplier management programs to ensure compliance with Current Good Manufacturing Practices (CGMP) regulations.
This role involves providing guidance on daily quality issues, analyzing data, and implementing corrective actions to maintain CGMP compliance.
The Quality Assurance Manager will also be responsible for:
- Developing and maintaining Standard Operating Procedures (SOPs) to ensure compliance with CGMP requirements and product quality standards.
- Overseeing batch review and disposition processes to ensure products meet CGMP requirements and investigating unexplained discrepancies.
- Managing Quality department metrics for Management Review and routine Key Performance Indicators (KPIs).
- Serving as QA subject matter expert during regulatory inspections and customer audits.
- Performing deviation and CAPA investigations to identify root causes, implement corrective actions, and verify their effectiveness.
We are looking for a highly skilled professional with:
- A minimum of 5-7 years of experience in a CGMP environment, preferably in a leadership or decision-making role.
- Bachelor's degree in a related field.
- Comprehensive knowledge of applicable FDA regulations and guidance documents.
- Previous experience participating in regulatory inspections and customer audits.
- Strong analytical skills and ability to communicate complex information effectively.
We offer a competitive salary range of $100,000 - $110,000 per year, depending on experience. If you are a motivated and detail-oriented professional with a passion for quality assurance, please apply.
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