Remote Clinical Quality Operations Lead

Merck; Juneau (AK); Remote; USD 142,000 - 224,000; Full time

Job summary

Merck in Rahway, NJ seeks a seasoned Clinical Quality Operations professional to oversee quality activities across trials, ensuring inspection readiness and robust supplier oversight.

You will lead RCA/CAPA processes, coordinate regulatory commitments, and collaborate with CQO teams to embed Quality by Design in trial conduct. The role emphasizes cross-functional leadership and strategic risk management.

Qualifications

• Bachelor’s or Master’s Degree or equivalent in a health care or scientific area.
• 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 QMS, ICH GCP guidelines, and worldwide Regulatory Health Authority requirements.
• Advanced 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 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 and Serious Breaches.
• Support Trial Teams in assessing trial health and conducting quality reviews, as needed.
• Lead Inspection Hypercare Teams to ensure ongoing inspection readiness.
• Provide oversight for sponsor inspections and act as Inspection Lead for site inspections.
• Coordinate inspection responses with root cause analysis, CAPA, and regulatory commitments.

Skills

CAPA Management

Clinical Quality Management

Communication

Cross-Functional Teamwork

Data Analysis

Good Clinical Practice

Process Improvements

Project Management

Regulatory Compliance

Regulatory Inspections

Risk Management

Root Cause Analysis

Strategic Thinking

Taking Initiative

Education

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

Job description

Merck in Rahway, NJ seeks a seasoned Clinical Quality Operations professional to oversee quality activities across trials, ensuring inspection readiness and robust supplier oversight.

You will lead RCA/CAPA processes, coordinate regulatory commitments, and collaborate with CQO teams to embed Quality by Design in trial conduct. The role emphasizes cross-functional leadership and strategic risk management.