Remote Senior Clinical Quality Operations Manager

Merck & Co.; North Wales (Montgomery County); Remote; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) retirement plan

Paid holidays

Vacation

Compassionate and sick days

Job summary

Merck & Co. is seeking a Clinical Quality Operations Manager to drive high-quality data from global clinical trials and to oversee quality processes across trial teams.

You will manage inspections, CAPA programs, and risk management with cross-functional teams to ensure compliance with ICH GCP and global regulations. Responsibilities include leading inspection readiness activities, coordinating sponsor inspections, and supporting QA audits while guiding service providers on quality standards.

Qualifications

• Bachelor's or Master's Degree or equivalent in a health care or scientific area.
• Minimum 8 years in pharma/clinical research.
• Knowledge of QMS, ICH GCP, and worldwide regulatory requirements.
• Advanced RCA, CAPA development and effectiveness management.
• Experience in service provider quality oversight.

Responsibilities

• Provide clinical quality oversight to Trial Teams and lead inspection readiness.
• Coordinate inspection responses, CAPA, and root cause analyses.
• Lead Inspection Hypercare Teams to maintain ongoing readiness.
• Oversee operational management of sponsor inspections and site inspections.
• Support QA audits and study-level observations with corrective actions.
• Collaborate on risk management with the Clinical Quality Risk Manager.

Skills

Communication

Project management

Cross-functional teamwork

Ability to lead

Data analysis

Regulatory compliance

Taking initiative

Education

Bachelor's or Master's in health care or scientific field

Job description

Merck & Co. is seeking a Clinical Quality Operations Manager to drive high-quality data from global clinical trials and to oversee quality processes across trial teams.

You will manage inspections, CAPA programs, and risk management with cross-functional teams to ensure compliance with ICH GCP and global regulations. Responsibilities include leading inspection readiness activities, coordinating sponsor inspections, and supporting QA audits while guiding service providers on quality standards.