Quality Manager (Regulated Industry)
On-site · San Francisco, California, United States or Boston, Massachusetts, United States
Job Summary
Quality Manager in a regulated life sciences environment responsible for establishing and enforcing the Quality Management System (QMS) across Mentor and client facilities, leading events and root cause analyses, overseeing training programs and inspection readiness, managing SLAs and quality requirements, and developing strategies to meet client needs. The role includes ownership of CAPA/non-conformance processes, audits, vendor management, and continuous improvement initiatives across multiple sites; requires bilingual (English/Spanish) communication, strong technical writing, and willingness to travel to client locations (Durham, NC; Boston, MA; San Francisco, CA; Caguas, PR).
Required Qualifications
- Bachelor's degree in sciences or engineering (required)
- Minimum of five (5) years professional experience in compliance, quality systems and/or internal auditing within the regulated industry
- Experience leading teams or projects
- Strong technical writing skills (English and Spanish)
- Proficiency with MS Office and Quality Management Systems (e.g., Trackwise)
- Knowledge of GMP, GDP and ISO standards
- Ability to train and develop staff
- Ability to travel to client sites as required
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