Remote Clinical Quality Operations Manager

Merck; Montgomery (AL); Remote; USD 142,000 - 224,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Medical, dental, vision benefits

Job summary

Merck in Rahway, NJ seeks a Clinical Quality Operations Manager to lead quality oversight across trials, ensure regulatory GCP compliance, and maintain ongoing inspection readiness worldwide.

You will collaborate with the CQOL and CQO, guide Trial Teams, manage CAPA and root cause analyses, and coordinate sponsor inspections and vendor QA. Requires a bachelor’s or master’s in a health/science field and at least 8 years in pharma or clinical research.

Qualifications

• Bachelor’s or Master’s Degree in a health care or scientific field.
• Minimum of 8 years of relevant experience in the pharmaceutical industry and/or clinical research.
• Robust knowledge of quality management and clinical trial operations.
• Comprehensive knowledge of ICH GCP guidelines and worldwide regulatory health authority requirements.
• Advanced experience in RCA, CAPA development and effectiveness management, and service provider quality oversight.

Responsibilities

• Independently support assigned Trial Teams and drive implementation of Quality by Design.
• Act as a Process Subject Matter Expert (SME) within Clinical Quality Operations, providing guidance on quality processes, standards, and regulatory requirements to Trial Teams.
• Support identification, investigation, escalation, and resolution of study-level quality issues including Significant Quality Issues (SQIs) and Serious Breaches (SBs).
• Support Trial Teams in assessing trial health and conducting quality reviews, as needed.
• Lead Inspection Hypercare Teams (IHT) to ensure ongoing inspection readiness.
• Provide oversight for sponsor inspections (e.g., act as Control Room Lead or Control Room Support).
• Act as Inspection Lead for site inspections and conduct pre-inspection visits (PIV).
• Coordinate inspection response processes with root cause analysis, CAPA and regulatory commitments.
• Support Quality Assurance audits (Study Level Audits) including CAPA management and tracking.

Skills

CAPA Management

Clinical Quality Management

Communication

Cross-Functional Teamwork

Data Analysis

GCP (Good Clinical Practice)

Process Improvements

Project Management

Regulatory Compliance

Regulatory Inspections

Risk Management

Root Cause Identification

Strategic Thinking

Taking Initiative

Education

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

Job description

Merck in Rahway, NJ seeks a Clinical Quality Operations Manager to lead quality oversight across trials, ensure regulatory GCP compliance, and maintain ongoing inspection readiness worldwide.

You will collaborate with the CQOL and CQO, guide Trial Teams, manage CAPA and root cause analyses, and coordinate sponsor inspections and vendor QA. Requires a bachelor’s or master’s in a health/science field and at least 8 years in pharma or clinical research.