Associate Director, Quality Assurance
$129k - $203.1kMerck
Merck's Research & Development Division seeks an Associate Director for Quality Assurance to provide independent oversight of clinical trial safety, participant rights, and data integrity. This role focuses on conducting GCP audits, managing quality issues, and supporting global compliance across investigator sites and suppliers, with significant travel to China.
Responsibilities
- Prepare, conduct, and report on QA audits at investigator sites, country offices, and suppliers
- Analyze quality factors and design risk-based audits to identify compliance risks
- Collaborate with global teams to manage quality issues and implement corrective actions
- Participate in significant quality issue assessments and escalate findings appropriately
- Support audit scheduling and substrate identification in collaboration with regional leads
Requirements
- Bachelor's degree or equivalent qualification
- Minimum 5 years of experience in quality assurance or related field
- Expertise in GCP audits, quality risk management, and regulatory compliance
- Strong audit management and deviation investigation skills
- Ability to travel 75% to Asia Pacific region, including 2-3 week quarterly stays in China
- Demonstrated influencing, negotiation, and stakeholder communication abilities
Compensation: $129,000.00 - $203,100.00
Vacancy posted 3 days ago
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