Clinical Quality Operations Lead

Merck; Honolulu (HI); Remote; USD 120,000 - 160,000; Full time

Job summary

Merck is seeking a Senior Clinical Quality Operations Manager to oversee quality activities across global trials, ensuring compliance with ICH GCP and QMS standards. The role emphasizes proactive quality oversight, inspection readiness, and risk-based approaches in collaboration with CQOL and the Head of CQO.

You will lead inspection readiness, sponsor inspections, CAPA development, and risk-based quality oversight, partnering with trial teams and service providers to embed quality by design and

Qualifications

• Bachelor’s or Master’s degree in healthcare or science.
• 8+ years of pharma/clinical research experience.
• Knowledge of QMS, ICH GCP, and regulatory requirements.

Responsibilities

• Lead inspection readiness and inspection management activities.
• Provide oversight for trial teams and sponsor quality activities.
• Coordinate root-cause analysis, CAPA development and effectiveness management.
• Support risk-based quality oversight and QA audits across trials.
• Develop and drive CQO infrastructure and special projects.

Skills

Quality management

Clinical trial operations

Root cause analysis

CAPA management

Service provider quality oversight

Quality by Design

Audit & inspection readiness

Education

Bachelor's or Master’s degree in healthcare or science

Job description

Merck is seeking a Senior Clinical Quality Operations Manager to oversee quality activities across global trials, ensuring compliance with ICH GCP and QMS standards. The role emphasizes proactive quality oversight, inspection readiness, and risk-based approaches in collaboration with CQOL and the Head of CQO.

You will lead inspection readiness, sponsor inspections, CAPA development, and risk-based quality oversight, partnering with trial teams and service providers to embed quality by design and