Clinical Quality Operations Lead

Merck; Helena (MT); Remote; USD 120,000 - 150,000; Full time

Job summary

Merck seeks a senior Clinical Quality Operations professional to oversee trial quality, risk management, and inspection readiness. You will lead root cause analyses, CAPA development, and regulatory communication while collaborating with CQO leadership to sustain world‑class standards.

In this role, you will supervise inspection activities, coordinate quality oversight for external providers, and contribute to CQO innovations.

Qualifications

• Bachelor’s or Master’s Degree in healthcare or scientific area required.
• Minimum 8 years of relevant pharma/clinical research experience.
• Strong knowledge of ICH GCP guidelines and global regulatory requirements.
• Experience in RCA, CAPA development, and QA oversight.

Responsibilities

• Provide clinical quality oversight for trials, ensuring quality by design across trial teams.
• Lead inspection readiness activities and act as Inspection Lead for site visits.
• Coordinate CAPA programs and root cause analyses for quality issues.
• Support sponsor inspections and regulatory audit preparations and responses.
• Oversee service provider quality agreements and performance.
• Contribute to CQO process improvements and specialized projects.

Skills

Quality management

RCA

CAPA development

Regulatory knowledge

GCP compliance

Audit coordination

Service provider oversight

Education

Bachelor’s or Master’s Degree in healthcare or life sciences

Tools

QMS software

Audit management tools

Job description

Merck seeks a senior Clinical Quality Operations professional to oversee trial quality, risk management, and inspection readiness. You will lead root cause analyses, CAPA development, and regulatory communication while collaborating with CQO leadership to sustain world‑class standards.

In this role, you will supervise inspection activities, coordinate quality oversight for external providers, and contribute to CQO innovations.