Quality Manager
A leading third-party logistics (3PL) provider specializing in pharmaceutical and life sciences distribution is seeking a seasoned Quality Manager to lead quality assurance and compliance initiatives across its Memphis operations. This role is critical to ensuring adherence to FDA and DEA regulations and maintaining the highest standards of product integrity and operational excellence.
What You'll Be Doing:
- Oversee the site's Quality Management System (QMS), ensuring compliance with FDA, DEA, and other applicable regulatory requirements.
- Lead internal and external audits, including regulatory inspections and client quality reviews.
- Manage CAPA, deviation, change control, and complaint handling processes.
- Collaborate cross-functionally with operations, regulatory affairs, and client services to ensure quality standards are met throughout the distribution lifecycle.
- Develop and implement SOPs, training programs, and continuous improvement initiatives.
- Serve as the primary quality contact for regulatory bodies and client partners.
- Monitor and report on key quality metrics and drive root cause analysis and corrective actions.
What You Bring:
- Bachelor's degree in Life Sciences, Engineering, or a related field; advanced degree preferred.
- Minimum of 10 years of experience in manufacturing and/or distribution within the pharmaceutical or life sciences industry.
- Strong working knowledge of FDA and DEA regulations, including cGMP and GDP.
- Experience in a 3PL or logistics/distribution environment is highly desirable.
- Proven leadership in quality systems, audits, and regulatory compliance.
- Excellent communication, analytical, and problem-solving skills.
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