Senior QA Lead, Clinical Quality & Audits

Merck; Austin (TX); Remote; USD 129,000 - 203,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Paid holidays

Vacation

Job summary

Merck & Co., Inc. is seeking a QA Clinical Quality professional to ensure data integrity and regulatory compliance across global clinical trials. You will plan and perform QA audits, collaborate with China teams on GCP and regulatory matters, and ensure timely CAPAs and risk mitigation.

The role requires 75% travel (Asia Pacific, incl. China) and an emphasis on cross-functional coordination with Clinical Operations and QA management.

Qualifications

• Bachelor's degree (BS/BA) or equivalent preferred.
• Minimum of 5 years of experience in a relevant field.
• Ability to travel 75% (Asia Pacific incl. China) for audits and collaboration.

Responsibilities

• Prepares, conducts QA audits and generates audit reports.
• Collaborate with teams in China to align on GCP and regulatory requirements.
• Analyze quality factors to identify risks and perform risk-based audits.
• Perform GCP audits of investigator sites, country offices, and third parties.
• Support QALs in audit substrate identification in China.
• Travel 75% in Asia Pacific, including China and ROW as needed.

Skills

Influence/Negotiation

Ownership and Accountability

Execution Excellence

Networking and Partnerships

Coaching and Development

Talent Growth

Education

Bachelor's degree (BS/BA) or equivalent

Minimum 5 years of experience

Job description

Merck & Co., Inc. is seeking a QA Clinical Quality professional to ensure data integrity and regulatory compliance across global clinical trials. You will plan and perform QA audits, collaborate with China teams on GCP and regulatory matters, and ensure timely CAPAs and risk mitigation.

The role requires 75% travel (Asia Pacific, incl. China) and an emphasis on cross-functional coordination with Clinical Operations and QA management.