[Hiring] Associate Director, Quality Assurance @MSD

Role Description

Our Research & Development Division QA Clinical Quality (CQ) provides independent assurance that our Company ensures the safety, rights, and well-being of participants, while complying with applicable global regulatory requirements through sound processes, procedures, and strategies for ensuring data integrity in our clinical trials.

• Prepares, conducts QA audits, including prolonged auditing in China.
• Generates audit reports and communicates results to relevant QA management and external stakeholders (e.g. Clinical Operations).
• Interacts with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable.
• Collaborates with colleagues in China to understand cultural considerations, responsibilities for work in global studies, and local regulations in China related to GCP and new drug applications.
• Analyzes and leverages critical to quality factors to identify potential risks for risk-based audits.
• Conducts GCP routine and directed audits of investigator sites, country offices, suppliers, third-party collaborations, and due diligence activities.
• Supports the QALs in the identification of audit substrate in China for scheduling, as appropriate.
• Ability to travel to/within China; extended stay in country (2-3 weeks per quarter).
• Travel: 75% - Asia Pacific (China), including ROW as needed.

Qualifications

• Bachelor's degree (BS/BA) or equivalent preferred.
• Minimum of 5 years of experience in a relevant field.

Requirements

• Accountability
• Action Plan Development
• Adaptability
• Audit Management
• Building Partnerships
• Compliance Investigations
• Deviation Management
• Global Program Development
• Impact Analysis
• Influencing Skills
• Proactive Behavior
• Proactive Thinking
• Project Leadership
• Project Risk Assessments
• Quality Assurance Processes
• Quality Assurance Systems
• Quality Auditing
• Quality Oversight
• Quality Reporting
• Quality Risk Management
• Quality Systems Compliance
• Regulatory Compliance
• Results-Oriented
• Setting Performance Standards

Benefits

• Comprehensive package of benefits including medical, dental, vision healthcare, and other insurance benefits (for employee and family).
• Retirement benefits, including 401(k).
• Paid holidays, vacation, and compassionate and sick days.