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Senior Quality Manager

Senior Quality Manager

About the role

To perform this job successfully, the essential functions of this job include, but are not limited to:

• Excipient technical experience, supplier quality management, and team leadership, ensuring compliance with Good Manufacturing Practices (GMP) for bulk pharmaceutical excipients as outlined in USP <1078>.
• Act as the technical resource and liaison between customers, employees, internal stakeholders, third-party manufacturers, and suppliers.
• Oversee Quality System performance and site KPI’s and develop Strategic Quality Goal Plan for site.
• Perform investigations pertaining to out-of-spec and critical limit deviations.

•Oversee complaint and non-conformance trend investigations to prevent reoccurrence
• Change Leader and coordinate change control activities.
• Review customer specifications, quality agreements, questionnaires, etc.
 • Act as the primary liaison for customer and regulatory agency audits.
• Participate on cross functional teams to ensure the continuous, on-going improvement of processes, methods, productivity, and quality while reducing costs.
• Ensure compliance for all documentations and records to meet system and regulatory requirements.


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Additional Info

Job Type : Full-Time

Education Level : Bachelors Degree

Experience Level : Mid to Senior Level

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