Quality Manager (Regulated Industry)
On-siteWoodbridge, Virginia, United States
Job Summary
Establish quality management systems and oversee client facilities compliance with GMP, GDP, and ISO standards. Lead root cause analysis, audit investigations, and corrective/preventive action plans while managing vendor and training programs. Review and approve protocols, operating procedures, and work instructions to ensure operational clarity and efficiency. Implement continuous improvement strategies across multiple sites and coordinate with internal departments to meet customer-driven goals. Travel to support client operations as required. Bachelor's degree with five years of regulated industry experience; fluent in English and Spanish.
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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