Senior Clinical Quality Operations Manager - Remote

MSD; Rahway (NJ); À distance; USD 140 000 - 190 000; Plein temps

Résumé du poste

MSD is seeking a qualified professional to drive clinical quality oversight across trials, with emphasis on risk-based quality management and inspection readiness. You will partner with CQOL and CQO leadership to embed quality into trial delivery and supplier oversight.

The role requires extensive experience in QA/CMC, GCP, and regulatory inspections, plus strong cross-functional leadership and problem-solving skills. Remote work options are available globally.

Qualifications

• Minimum of 8 years of relevant experience in the pharmaceutical industry and/or clinical research.
• Robust knowledge of Quality Management Systems (QMS), ICH GCP guidelines, and worldwide Regulatory Health Authority requirements.
• Advanced experience in independent root cause analysis (RCA), CAPA development and effectiveness management, and service provider quality oversight.

Responsabilités

• Support Trial Teams in embedding quality into sponsored trials and oversight of SQIs and SBs.
• Lead Inspection Hypercare Teams (IHT) to ensure ongoing inspection readiness.
• Coordinate CAPA processes and root cause analyses for regulatory commitments.
• Provide SME guidance on quality processes, standards, and regulatory requirements to Trial Teams.

Connaissances

Quality management

GxP Compliance

CAPA

Root cause analysis

Cross-functional leadership

Project management

Communication

Data analysis

Formation

Bachelor’s or Master’s Degree in Health Care or Science

Outils

QMS software

Regulatory databases

Description du poste

MSD is seeking a qualified professional to drive clinical quality oversight across trials, with emphasis on risk-based quality management and inspection readiness. You will partner with CQOL and CQO leadership to embed quality into trial delivery and supplier oversight.

The role requires extensive experience in QA/CMC, GCP, and regulatory inspections, plus strong cross-functional leadership and problem-solving skills. Remote work options are available globally.