Remote Clinical Quality Operations Manager

Merck; Montpelier (VT); Remote; USD 142,000 - 224,000; Full time

Job summary

Merck & Co., Inc. seeks a senior Clinical Quality Operations leader to oversee quality oversight for global trials. You will embed quality into trial teams, manage CAPA and RCA, and direct inspection readiness activities in collaboration with CQO leadership.

Ideal candidates have 8+ years in pharma/clinical research, deep knowledge of GCP and QMS, and a track record of working with cross-functional teams to ensure regulatory compliance and risk-based quality management.

Qualifications

• Minimum 8 years in pharmaceutical industry and/or clinical research.
• Strong knowledge of QMS, ICH GCP, and global regulatory requirements.
• Advanced RCA, CAPA development and effectiveness management experience.
• Experience in service provider quality oversight and inspections.

Responsibilities

• Support execution of clinical quality oversight activities with QA leadership.
• Lead inspection readiness, CAPA, and regulatory commitments for trials.
• Coordinate root cause analysis and corrective actions for quality issues.
• Collaborate with trial teams to embed quality by design and risk-based oversight.
• Oversee sponsor inspections and site inspections as needed.
• Contribute to CQO infrastructure and AI-driven efficiency improvements.

Skills

Quality Management

Clinical Operations

CAPA

Root Cause Analysis

GCP

Regulatory Compliance

Project Management

Cross-Functional Leadership

Data Analysis

Strategic Thinking

Education

Bachelor’s or Master’s Degree in healthcare or science field

Job description

Merck & Co., Inc. seeks a senior Clinical Quality Operations leader to oversee quality oversight for global trials. You will embed quality into trial teams, manage CAPA and RCA, and direct inspection readiness activities in collaboration with CQO leadership.

Ideal candidates have 8+ years in pharma/clinical research, deep knowledge of GCP and QMS, and a track record of working with cross-functional teams to ensure regulatory compliance and risk-based quality management.