Clinical Quality Operations Manager - Remote

Merck & Co., Inc.

Job Overview

Location

3 Locations

Job Type

Full-time

Full Job Description

📋 Description

• The Clinical Quality Operations Manager (CQOM) at Merck & Co., Inc. is a critical role responsible for embedding quality by design into clinical development programs and ensuring inspection readiness across global clinical trials within an assigned therapeutic area. This position directly supports Merck’s commitment to regulatory compliance, patient safety, and the integrity of clinical data by overseeing operational quality management, inspection preparedness, and CAPA execution in partnership with cross-functional teams.
• Day-to-day responsibilities include developing and implementing quality plans and risk assessment tools using a risk-based approach; overseeing vendor oversight and third-party activities; facilitating responses to audit and inspection observations; maintaining current knowledge of global GCP and regulatory requirements (FDA, EMA, NMPA, etc.); contributing to the standardization of Clinical Quality Operations procedures, tools, and templates; leading inspection readiness efforts including strategy development, cross-functional team coordination, and management of the global inspection tracking system; ensuring timely completion and documentation of CAPAs and regulatory commitments; providing input to the GCP Quality and Compliance Council; and driving process improvement and training initiatives to strengthen inspection readiness.
• The CQOM operates within Merck’s Clinical Quality Organization (CQO), partnering closely with the Clinical Quality Operations Lead (CQOL) and Head of CQO, while collaborating with Clinical Trial Teams (CTTs), Global Clinical Trial Operations (GCTO), Quality & Continuous Improvement (QCI), Pharmacovigilance (PV), GRACS, IT, and regional study management to ensure alignment and effectiveness across the clinical study lifecycle.
• This role offers the opportunity to deepen expertise in global clinical quality systems, regulatory inspection management, and risk-based quality oversight; develop leadership and influence skills in a complex, matrixed environment; contribute to company-wide standardization efforts; and gain strategic visibility into Merck’s clinical development and compliance operations, positioning the individual for advancement within quality, regulatory, or clinical operations leadership.

🎯 Requirements

• Minimum of 6 years in clinical research, including at least 2 years developing and managing clinical quality systems and overseeing regulatory inspections.
• Expert knowledge of GCP/ICH guidelines and worldwide Regulatory Health Authority requirements (e.g., FDA, EMA, NMPA).
• Proven ability to develop and implement effective CAPA management solutions and use risk management tools within a clinical quality framework.
• Superior oral and written communication skills for international collaboration; ability to lead cross-functional teams and influence stakeholders at all levels.
• Excellent project management, organizational, and strategic thinking skills with demonstrated ability to analyze complex problems and drive process improvements.
• Bachelor’s or Master’s degree in a relevant healthcare field; additional formal education in quality or business management preferred.

🏖️ Benefits

• Competitive salary range of $142,400.00 to $224,100.00, with eligibility for annual bonus and long-term incentives.
• Comprehensive benefits package including medical, dental, vision, retirement (401(k)), paid holidays, vacation, and sick/compassionate leave.
• Remote work arrangement with 25% travel requirement, supporting flexibility while maintaining engagement with global teams.
• Access to professional development opportunities and training in evolving areas such as digital data management and emerging regulatory trends.
• Commitment to inclusion, equal opportunity, and accommodation support during the hiring process.
• Employee-focused culture emphasizing innovation, diverse perspectives, and collaborative problem-solving.

Skills & Technologies

GCP

Remote

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Merck & Co., Inc.

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About Merck & Co., Inc.

Merck & Co., Inc., operating as MSD outside the United States and Canada, is a global biopharmaceutical company that discovers, develops, manufactures and markets prescription medicines, vaccines, biologic therapies and animal health products. Its research focuses on oncology, infectious diseases, vaccines, hospital acute care, immunology and neuroscience. Founded in 1891 and headquartered in Rahway, New Jersey, the company operates in more than 140 countries, employing over 70,000 people worldwide and selling products through its global network of subsidiaries and distributors.

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