Clinical Quality Operations Lead (Trials & Inspections)

Merck; Lincoln (NE); Remote; USD 120,000 - 160,000; Full time

Job summary

Merck is seeking a senior Clinical Quality Operations professional to oversee quality management for worldwide clinical trials. You will lead inspection readiness, coordinate sponsor inspections, and guide QA audits across trial teams, applying risk-based oversight and Quality by Design principles.

The role requires 8+ years in pharma/clinical research, strong knowledge of QMS and ICH GCP, and expertise in RCA and CAPA. Collaborative leadership within CQO is essential.

Qualifications

• Bachelor’s or Master’s Degree or equivalent in a health care or scientific area.
• 8+ years of relevant experience in pharma/clinical research.
• Strong knowledge of QMS, ICH GCP, and worldwide regulatory requirements.
• Advanced RCA, CAPA development and effectiveness management, and service provider oversight.

Responsibilities

• Support Trial Teams and drive Quality by Design implementation.
• Act as Process 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 maintain ongoing inspection readiness.
• Provide oversight for sponsor inspections ( Control Room Lead/Support).
• Act as Inspection Lead for site inspections and conduct pre-inspection visits.
• Author inspection communications and manage CAPA-driven responses and regulatory commitments.
• Coordinate QA audits, root cause analysis, and development of corrective actions.

Skills

Quality management

Root cause analysis

CAPA development

Inspection leadership

Process SME

Risk-based quality oversight

Audit coordination

Education

Bachelor’s or Master’s Degree in health care/science

Tools

QMS

Job description

Merck is seeking a senior Clinical Quality Operations professional to oversee quality management for worldwide clinical trials. You will lead inspection readiness, coordinate sponsor inspections, and guide QA audits across trial teams, applying risk-based oversight and Quality by Design principles.

The role requires 8+ years in pharma/clinical research, strong knowledge of QMS and ICH GCP, and expertise in RCA and CAPA. Collaborative leadership within CQO is essential.