Clinical Quality Operations Manager- Remote

Merck; Carson City (NV); À distance; USD 120 000 - 180 000; Plein temps

Résumé du poste

Merck is seeking a senior Clinical Quality Operations Manager to oversee quality activities across global trials, embedding Quality by Design and proactive oversight of sponsor studies.

You will lead inspection readiness, CAPA and root cause analyses, audits, and collaborations with CQO leadership to ensure regulatory compliance and continuous improvement.

Qualifications

• Bachelor’s or Master’s Degree in health care or scientific area.
• Minimum of 8 years of relevant pharma and/or clinical research experience.
• Strong knowledge of Quality Management Systems (QMS), ICH GCP guidelines and global regulatory requirements.
• Advanced experience in root cause analysis (RCA), CAPA development and effectiveness management.
• Experience in service provider quality oversight and audits.

Responsabilités

• Independently support Trial Teams and drive Quality by Design implementation.
• Act as an SME on quality processes, standards, and regulatory requirements for trials.
• Support identification, investigation, escalation, and resolution of study-level quality issues including SQIs and SBs.
• Lead Inspection Hypercare Teams to maintain ongoing inspection readiness at all stages.
• Coordinate inspection responses, root cause analyses, CAPA and regulatory commitments.

Connaissances

Quality management

Regulatory requirements

Root cause analysis

CAPA management

Inspection readiness

Quality Assurance audits

Service provider oversight

Formation

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

Description du poste

Job Description

It is critical that consistent, accurate, high-quality data is generated and maintained from clinical trials conducted worldwide. In collaboration with the Clinical Quality Operations Lead (CQOL) and Head of CQO, the CQOM is responsible for the execution of clinical quality oversight activities within an assigned trial. This includes proactive quality management, risk-based quality oversight, and clinical trial inspection management activities.

The CQOM will provide clinical quality operations support to Trial Teams (TTs) to proactively embed quality into sponsored trials, ensure robust supplier oversight, and address critical quality issues as needed.

The incumbent will assist with the overall strategy for maintaining ongoing inspection readiness, as well as preparing for, managing, and following up on regulatory inspections.

Core Responsibilities:

Trial Team, Research Portfolio and Enterprise Support

• Independently support assigned Trial Teams (TT) and drive implementation of Quality by Design.
• Act as a Process Subject Matter Expert (SME) within Clinical Quality Operations, providing guidance on quality processes, standards, and regulatory requirements to TTs.
• Support identification, investigation, escalation, and resolution of study-level quality issues including Significant Quality Issues (SQIs) and Serious Breaches (SBs).
• Support Trial Teams in assessing trial health and conducting quality reviews, as needed.
• Lead Inspection Hypercare Teams (IHT) with the aim of ensuring that, at all stages, the Trial Team (TT) maintains ongoing inspection readiness.

Regulatory GCP Inspections & Research and Development Quality Assurance Audits

• Provide oversight for operational management of sponsor inspections (e.g., act as Control Room Lead or Control Room Support).
• Act as Inspection Lead for site inspections.
• Conduct pre-inspection visit (PIV) for impending site inspections.
• Author key inspection communications (e.g., daily summaries, inspection outcomes, and issue escalations).
• Coordinate the inspection response process managing the root cause analysis, Corrective and Preventive Action (CAPA) and associated regulatory commitments to completion, ensuring that key inspection documentation is maintained at all times.
• Support Quality Assurance audits (i.e., Study Level Audits) providing support to TT before, during and after audit, including coordinating root cause analysis for any applicable observations, development of responses, CAPA management and tracking.

Clinical Quality Risk Management

• Collaborate with the Clinical Quality Risk Manager (CQRM) to operationalize quality risk management during trial conduct.
• Provide critical insights from study level audits, inspections, and quality issues and support identification of actionable resolution pathways for quality signals that emerge during trial conduct.

Service Provider Quality Oversight

• Serve as the primary clinical quality Point of Contact (POC) for assigned key service providers (e.g., tier 1 and tier 2 service providers).
• Responsible for the strategic development and management of service provider clinical quality agreements.

Mergers & Acquisitions

• Support quality-related mergers and acquisitions activities, as required, to ensure comprehensive knowledge transfer, risk management, and inspection readiness.

CQO Infrastructure, Process Innovation & Special Projects

• Contribute to the ongoing development of CQO infrastructure and process innovation.
• Support and lead special projects and strategic assignments within CQO as assigned by CQOL.

AI Efficiency & Optimization

• Proactively identify and apply AI-driven approaches to improve operational efficiency and decision-making within CQO.
• Work with data and analytics to monitor performance and drive continuous improvement.

Qualifications, Skills & Experience

Education

• Bachelor’s or Master’s Degree or equivalent in a health care or scientific area.

Experience

• Minimum of 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 (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.