Remote Clinical Quality Operations Leader

Merck & Co.; Rahway (NJ); Remote; USD 180,000 - 240,000; Full time

Job summary

Merck & Co. in Rahway, NJ is seeking a seasoned Clinical Quality Operations Manager to oversee trial quality, risk management, and inspection readiness across global studies. You will partner with CQOL and CQO to embed quality, manage CAPAs, and coordinate sponsor inspections.

You will lead cross-functional teams, apply QA/QMS principles, and drive continuous improvement in regulatory compliance and trial integrity within a fast-paced pharmaceutical environment.

Qualifications

• Minimum of 8 years of relevant experience in the pharmaceutical industry and/or clinical research.
• Robust knowledge of quality management and clinical trial operations.
• Comprehensive knowledge of QMS, ICH GCP guidelines, and worldwide regulatory requirements.
• Advanced experience in RCA, CAPA development/effectiveness, and service provider oversight.

Responsibilities

• Support Trial Teams and drive Quality by Design implementation.
• Act as Process SME for quality processes and regulatory requirements.
• Identify, investigate, escalate, and resolve study-level quality issues.
• Lead Inspection Hypercare Teams to maintain ongoing inspection readiness.
• Coordinate sponsor inspections and pre-inspection visits.
• Prepare inspection communications and manage CAPA root cause analyses.

Skills

Communication

Project management

Cross-functional teamwork

Quality risk management

Regulatory compliance

CAPA management

GCP knowledge

Root cause analysis

Strategic thinking

Data analysis

Education

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

Job description

Merck & Co. in Rahway, NJ is seeking a seasoned Clinical Quality Operations Manager to oversee trial quality, risk management, and inspection readiness across global studies. You will partner with CQOL and CQO to embed quality, manage CAPAs, and coordinate sponsor inspections.

You will lead cross-functional teams, apply QA/QMS principles, and drive continuous improvement in regulatory compliance and trial integrity within a fast-paced pharmaceutical environment.