Remote Clinical Quality Operations Leader

Merck & Co.; West Point (PA); Remote; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) and retirement benefits

Paid holidays

Vacation

Sick days

Job summary

Merck & Co. in Rahway, NJ, seeks an experienced Clinical Quality Operations Manager to lead quality oversight across trials, inspections, and risk management. You will collaborate with the CQOL and CQO to ensure inspection readiness and robust CAPA processes.

The role emphasizes QA audits, service provider oversight, M&A quality integration, and AI-driven operational improvements, requiring 8+ years in pharma, GCP, and RCA expertise.

Qualifications

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

Responsibilities

• Support trial teams and drive Quality by Design implementations.
• Act as SME for quality processes, standards, and regulatory requirements.
• Identify, investigate, escalate, and resolve study-level quality issues including SQIs and SBs.
• Lead Inspection Hypercare Teams to ensure ongoing inspection readiness.
• Coordinate inspection responses, CAPA, and regulatory commitments.

Skills

Quality Oversight

CAPA Management

RCA

GCP Knowledge

Education

Bachelor's or Master's in health/science

Job description

Merck & Co. in Rahway, NJ, seeks an experienced Clinical Quality Operations Manager to lead quality oversight across trials, inspections, and risk management. You will collaborate with the CQOL and CQO to ensure inspection readiness and robust CAPA processes.

The role emphasizes QA audits, service provider oversight, M&A quality integration, and AI-driven operational improvements, requiring 8+ years in pharma, GCP, and RCA expertise.