Clinical Quality Operations Leader

Merck; Dover (DE); Remote; USD 120,000 - 180,000; Full time

Benefits offered by this job

Competitive compensation

Health benefits

Relocation assistance

Job summary

Merck seeks a senior Clinical Quality Operations Manager (CQOM) to oversee clinical quality across trials, collaborating with the CQOL and CQO leadership to embed quality in sponsored studies worldwide.

You will drive inspection readiness, oversee sponsor inspections, and lead CAPA and RCA efforts while coordinating quality audits and risk management to ensure compliance and continuous improvement across trial operations.

Qualifications

• Minimum 8 years of experience in pharmaceutical clinical research.
• Strong knowledge of QMS, ICH GCP, and regulatory requirements.
• Expertise in RCA, CAPA development and effectiveness.
• Experience with inspections and sponsor/site inspections.
• Proven ability to lead cross-functional teams.

Responsibilities

• Support Trial Teams (TTs) and drive Quality by Design implementation.
• Act as Process SME for quality processes, standards, and regulatory requirements.
• Support identification, investigation, escalation, and resolution of quality issues including SQIs and SBs.
• Lead Inspection Hypercare Teams to maintain ongoing inspection readiness.
• Coordinate inspection responses, CAPA, and regulatory commitments.

Skills

Quality management

Clinical quality operations

Regulatory compliance (ICH GCP)

Root cause analysis (RCA)

CAPA management

Inspection readiness

Cross-functional collaboration

Education

Bachelor’s or Master’s Degree in health care or scientific field

Job description

Merck seeks a senior Clinical Quality Operations Manager (CQOM) to oversee clinical quality across trials, collaborating with the CQOL and CQO leadership to embed quality in sponsored studies worldwide.

You will drive inspection readiness, oversee sponsor inspections, and lead CAPA and RCA efforts while coordinating quality audits and risk management to ensure compliance and continuous improvement across trial operations.