Clinical Quality Operations Lead

Merck; Cheyenne (WY); Remote; USD 120,000 - 150,000; Full time

Job summary

Merck is seeking a seasoned Clinical Quality professional to drive quality oversight and inspection readiness within global trials. You will serve as a SME for QA processes, support trial health assessments, and lead hypercare teams during inspections.

The role requires extensive experience in QMS, GCP, RCA, and CAPA, with a focus on regulatory compliance and risk management across sponsored studies.

Qualifications

• Minimum of 8 years in the pharmaceutical industry and/or clinical research.
• Strong knowledge of Quality Management Systems (QMS) and ICH GCP guidelines.
• Experience with RCA, CAPA development and effectiveness.
• Familiarity with regulatory health authority requirements.

Responsibilities

• Oversee quality oversight activities across trials and inspections.
• Lead Inspection Hypercare and manage CAPA responses.
• Coordinate RCA and CAPA to ensure inspection readiness.
• Collaborate with CQO teams on risk-based quality management.

Skills

Quality management

GCP compliance

CAPA management

Root cause analysis

Regulatory inspections

Risk management

Education

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

Job description

Merck is seeking a seasoned Clinical Quality professional to drive quality oversight and inspection readiness within global trials. You will serve as a SME for QA processes, support trial health assessments, and lead hypercare teams during inspections.

The role requires extensive experience in QMS, GCP, RCA, and CAPA, with a focus on regulatory compliance and risk management across sponsored studies.