Clinical Quality Operations Manager- Remote

MSD•North Wales, PA

1d•$142,400 - $224,100•Remote

About The Position

The Clinical Quality Operations Manager (CQOM) executes clinical quality oversight activities for assigned clinical trials in collaboration with the Clinical Quality Operations Lead (CQOL) and Head of Clinical Quality Operations. The role promotes proactive and risk-based quality management, embeds quality into sponsored trials, supports robust supplier oversight, addresses critical quality issues, and helps maintain ongoing inspection readiness. The CQOM also prepares for, manages, and follows up on regulatory inspections. The position provides quality operations support to Trial Teams, contributes to clinical quality risk management, and leads or supports inspection and audit activities, including root cause analysis, corrective and preventive actions (CAPAs), and regulatory commitments. The CQOM also oversees clinical quality relationships with assigned service providers, supports mergers and acquisitions as required, contributes to process innovation and special projects, and applies AI and data analytics to improve operational efficiency and decision-making.

Requirements

Bachelor’s or master’s degree, or equivalent, in a healthcare or scientific area.
At least 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 Quality Management Systems, ICH Good Clinical Practice guidelines, and worldwide regulatory health authority requirements.
Advanced experience in independent root cause analysis, CAPA development and effectiveness management, and service provider quality oversight.
Superior oral and written communication skills in an international, matrixed environment.
Excellent project management and organizational skills.
Ability to lead cross-functional teams of business and clinical professionals.
Ability to act urgently and decisively on worldwide health authority inspection matters.
Ability to analyze, interpret, and solve complex quality and compliance issues.
Strategic and objective thinking, with digital savvy and awareness of AI and machine learning tools.
Required skills include CAPA management, clinical quality management, communication, cross-functional teamwork, data analysis, Good Clinical Practice, process improvement, project management, regulatory compliance, regulatory inspections, risk management, root cause identification, strategic thinking, and taking initiative.

Responsibilities

Independently support assigned Trial Teams and drive implementation of Quality by Design.
Serve as a Clinical Quality Operations process subject matter expert, guiding Trial Teams on quality processes, standards, and regulatory requirements.
Support identification, investigation, escalation, and resolution of study-level quality issues, including Significant Quality Issues and Serious Breaches.
Support Trial Teams in assessing trial health and conducting quality reviews as needed.
Lead Inspection Hypercare Teams to maintain ongoing inspection readiness throughout the trial.
Oversee operational management of sponsor inspections, including serving as Control Room Lead or Control Room Support.
Serve as Inspection Lead for site inspections and conduct pre-inspection visits for impending site inspections.
Prepare key inspection communications, including daily summaries, inspection outcomes, and issue escalations.
Coordinate inspection responses, including root cause analysis, CAPA development and management, regulatory commitments, and maintenance of key inspection documentation.
Support Trial Teams before, during, and after study-level Quality Assurance audits, including coordinating root cause analysis, developing responses, and managing and tracking CAPAs.
Collaborate with the Clinical Quality Risk Manager to operationalize quality risk management during trial conduct.
Provide insights from study-level audits, inspections, and quality issues, and support actionable resolution pathways for quality signals.
Serve as the primary clinical quality point of contact for assigned key service providers.
Lead the strategic development and management of service provider clinical quality agreements.
Support quality-related mergers and acquisitions activities to enable knowledge transfer, risk management, and inspection readiness.
Contribute to development of Clinical Quality Operations infrastructure and process innovation.
Support and lead special projects and strategic assignments as assigned by the Clinical Quality Operations Lead.
Identify and apply AI-driven approaches to improve operational efficiency and decision-making within Clinical Quality Operations.
Work with data and analytics to monitor performance and drive continuous improvement.