Clinical QA Auditor — Remote, Data-Driven

MSD Malaysia

Fatih

On-site

TRY 2,812,000 - 3,937,000

Full time

7 days ago
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Job summary

MSD Malaysia is seeking an experienced QA Clinical Quality Auditor to ensure safety and data integrity in clinical trials, with emphasis on risk-based audits and analytics.

You will conduct audits, generate reports, and drive corrective actions while collaborating with Clinical Operations and QA teams. The role requires 50%–70% travel and a strong foundation in GCP and quality management.

Qualifications

  • BS/BA degree or equivalent in a relevant field and/or experience in a similar QA/clinical quality role.
  • Experience with QA audits, data analysis and risk-based auditing.
  • Familiarity with GCP, Quality Assurance systems and deviation management.

Responsibilities

  • Prepares, conducts QA audits, generates audit reports and communicates results to QA management and stakeholders.
  • Interacts with teams to ensure corrective and preventative actions are closed.
  • Applies data-driven approaches and quality metrics to detect trends and prioritize audits.
  • Supports GCP audits of investigator sites, study level, suppliers and third party collaborations.
  • Travel 50% - 70%.

Skills

Ownership and Accountability
Execution Excellence
Networking and Partnerships
Coaching and Development
Talent Growth

Education

BS/BA degree or equivalent

Job description

MSD Malaysia is seeking an experienced QA Clinical Quality Auditor to ensure safety and data integrity in clinical trials, with emphasis on risk-based audits and analytics.

You will conduct audits, generate reports, and drive corrective actions while collaborating with Clinical Operations and QA teams. The role requires 50%–70% travel and a strong foundation in GCP and quality management.

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