Global QA Audit Director – Travel-Heavy & Compliance

Merck; West Point (PA); Remote; USD 129,000 - 203,000; Full time

Job summary

Merck & Co., Inc. is seeking a QA Clinical Quality professional to lead and execute GCP-compliant audits across global studies, emphasizing risk-based approaches and data integrity in clinical trials.

The role involves collaboration with teams in Asia, travel up to 75% (primarily China/Asia Pacific), interaction with external stakeholders, and ensuring timely closure of observations while maintaining regulatory compliance.

Qualifications

• Bachelor's degree (BS/BA) or equivalent preferred.
• Minimum of 5 years of experience in a relevant field.
• Global regulatory compliance knowledge and GCP/audit experience preferred.

Responsibilities

• Prepares, conducts QA audits and generates audit reports; communicates results to QA management and stakeholders.
• Collaborate with colleagues in China to understand regulatory requirements in global studies and local China regulations (GCP, NDA).
• Analyze quality factors to identify risks and perform risk-based audits.
• GCP routine and directed audits of sites, offices, suppliers, and collaborators.
• Support QA Leads in identifying audit substrates in China for scheduling.

Skills

Influence/Negotiation

Ownership & Accountability

Execution Excellence

Networking & Partnerships

Coaching & Development

Talent Growth

Education

Bachelor's degree

Minimum 5 years experience

Job description

Merck & Co., Inc. is seeking a QA Clinical Quality professional to lead and execute GCP-compliant audits across global studies, emphasizing risk-based approaches and data integrity in clinical trials.

The role involves collaboration with teams in Asia, travel up to 75% (primarily China/Asia Pacific), interaction with external stakeholders, and ensuring timely closure of observations while maintaining regulatory compliance.