Trachelle Clark
Sr. Manager, Gxp Compliance Officer
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About
Experienced Pharmaceutical and Biopharmaceutical Manufacturing Quality Operations and Regulatory Compliance Professional | Quality System Improvement | Instructional Design & GxP Trainer
Experience
Experienced Quality Systems and Regulatory Compliance Professional with over 20 years of progressive responsibility in pharmaceutical, biopharmaceutical, and medical device industries. Expertise in global cGMP regulations (US FDA 21 CFR Part 11, 210, 211, 820), ICH standards, and USP requirements. Proven success in leading cross-functional teams to implement robust quality systems, manage CMOs, and ensure compliance with regulatory requirements.
Adept at managing quality metrics, overseeing audits, and supporting product lifecycle management, including lot dispositions, CAPA, and change controls. Strong focus on continuous improvement and operational efficiency while maintaining a deep commitment to compliance.
Education
EDUCATION
Bachelor of Arts in Biology, Minor in Psychology
Metropolitan State University of Denver — 1994
CONTINUING EDUCATION
- Certified Quality Auditor & Quality Engineer (ASQ) Coursework
- Investigations and CAPA
- Supplier Quality Management
- Quality Auditing & Change Management
- Situational Leadership & Organizational Behavior
