Clinical Quality Ops Strategist – Trials & Inspections

Merck; Salem (OR); Remote; USD 120,000 - 160,000; Full time

Job summary

Merck in the United States is seeking an experienced Clinical Quality Operations Manager to oversee quality oversight for global trials. You will collaborate with CQOL and CQO leadership to ensure proactive quality management, risk-based oversight, and inspection readiness.

Responsibilities include leading trial team quality activities, acting as SME on quality processes, coordinating inspections and CAPA responses, and supporting QA audits across sponsor activities within a global portfolio.

Qualifications

• Bachelor’s or Master’s Degree in health care or scientific field.
• Minimum of 8 years of experience in the pharmaceutical industry and/or clinical research.
• Robust knowledge of Quality Management Systems (QMS), ICH GCP guidelines, and worldwide Regulatory Health Authority requirements.
• Advanced experience in independent root cause analysis (RCA), CAPA development and effectiveness management, and service provider quality oversight.

Responsibilities

• Lead Inspection Hypercare Teams (IHT) to ensure ongoing inspection readiness for trials.
• Act as Process SME within Clinical Quality Operations, guiding quality processes, standards, and regulatory requirements to Trial Teams.
• Coordinate identification, investigation, escalation, and resolution of study-level quality issues including SQIs and SBs.
• Support quality reviews, risk-based oversight, and sponsor inspections across trials.

Skills

Quality management

Clinical trial operations

ICH GCP guidelines

CAPA development

Root cause analysis

Inspection readiness

Regulatory compliance

Service provider oversight

Education

Bachelor’s or Master’s Degree in health care or scientific area

Job description

Merck in the United States is seeking an experienced Clinical Quality Operations Manager to oversee quality oversight for global trials. You will collaborate with CQOL and CQO leadership to ensure proactive quality management, risk-based oversight, and inspection readiness.

Responsibilities include leading trial team quality activities, acting as SME on quality processes, coordinating inspections and CAPA responses, and supporting QA audits across sponsor activities within a global portfolio.