Job Description

The Associate Clinical Quality Operations Manager (ACQOM) plays a key role in ensuring our company receives consistent, accurate, and high-quality clinical trial data worldwide. Working closely with the Clinical Quality Operations Lead (CQOL) and Head of CQO, the ACQOM supports operational quality management, risk management, inspection readiness, supplier oversight, and continuous quality improvement within assigned therapeutic areas.

Key Responsibilities

Clinical Trial Quality Support

Support Clinical Trial Teams embedding Quality by Design (QbD) principles throughout clinical development programs.
Conduct quality control activities to identify emerging study risks, process gaps, and quality issues.
Review quality documentation and trial quality folders for completeness and accuracy.
Assist with mergers, acquisitions, and integration activities to ensure knowledge transfer, risk mitigation, and inspection readiness.

Risk Management

Develop expertise in risk management tools and processes




Review critical data and processes throughout the clinical trial lifecycle to ensure risks are identified, monitored, and mitigated.

Regulatory Inspection Readiness

Support sponsor and investigator-site inspections and help maintain ongoing inspection readiness.
Participate in Inspection Support Teams (ISTs).
Manage and track Corrective and Preventive Actions and regulatory commitments through completion.
Perform quality reviews of inspection documentation repositories and support inspection response development.
Analyze inspection outcomes for trends and lessons learned.

Quality Assurance Audits

Assist with audit preparation, facilitation, root cause analysis, response development, and CAPA management.
Provide project management support for audit-related activities and CAPA implementation.

Third-Party Supplier Oversight

Support oversight of clinical research vendors and suppliers to ensure compliance and quality performance.
Assist with quality agreeme

📌 Associate Clinical Quality Operations Manager, Oncology III (Lima)
🏢 MSD LATAM
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