Quality Manager (Regulated Industry)
On-siteJacksonville, North Carolina, United States
Job Summary
Establish and enforce the Quality Management System for FDA-regulated clients, leading root cause analysis, inspection readiness, and vendor management programs. Manage the creation, revision, and oversight of quality protocols, operating procedures, and work instructions while coordinating training for system changes. Direct the implementation of corrective and preventive actions, monitor CAPA non-conformances, and lead continuous improvement projects across multiple sites. Conduct and support audit investigations, manage regulatory aspects including external audits, and act as the primary contact for compliance requests from customers and suppliers. Ensure employee adherence to standard operating procedures and drive strategy to meet client requirements.
Required Qualifications
- Bachelor's degree
- Sciences or Engineering
- Minimum of five (5) years professional experience in compliance, quality systems and/or internal auditing within the regulated industry
- Previous experience leading teams or projects
- Strong technical writing skills (English and Spanish)
- Ability to effectively read, write and verbally communicate in English and Spanish
- Computer literacy with MS Office applications (Word, Excel, Power Point, Outlook) and Quality Management Systems (e.g. Trackwise)
- Above average organizing, analyzing and a minimum of math (practical application of fractions, percentages, ratios, proportions, basic algebra) to determine organizational, Customer and regulatory problems and formulate corrective action plans
- Ability to adapt to changing responsibilities
- Effective interpersonal skills as demonstrated through prior experience
- Ability to work independently under minimal guidelines and supervision
- Working knowledge of applicable regulations and standards, including, but not limited to, GMP, GDP regulations and ISO standards
- Ability to motivate, train and develop staff within the MENTOR's team
- Willingness to demonstrate through daily activities a model of continuous monitoring of quality system activities to ensure compliance with documented standards
- Demonstrated ability to analyze data and performance metrics
- Demonstrate decision making capabilities
- Willingness to travel to support MTG clients and operations as required
Desired Qualifications
- Sciences or Engineering
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