Clinical Quality Operations Manager

🔥 3 minutes ago

🏖️ New Jersey, Pennsylvania – Remote

🏖️ New Jersey – Remote 🔔 Pennsylvania – Remote

💵 $142.4k - $224.1k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🏥 Clinical Operations

🦅 H1B Visa Sponsor

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MSD

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1891

🏥 Healthcare

📦 Logistics

🧬 Biotechnology

Healthcare • Logistics • Biotechnology

MSD is a leading biopharmaceutical company known as Merck & Co. , Inc. in the United States, Canada, and Puerto Rico, and as MSD globally. The company focuses on scientific innovation to deliver medicines and vaccines for various health challenges, including oncology, vaccines, infectious diseases, and cardio-metabolic diseases. MSD operates multiple divisions, including Human Health, Animal Health, and Research & Development. With approximately 75,000 employees worldwide and a significant investment in research and development, MSD is committed to improving global health through its scientific advancements. Additionally, the company places a strong emphasis on diversity, inclusion, and corporate responsibility. MSD’s operations extend worldwide, offering opportunities in numerous regions and promoting diversity and innovation in all aspects of its business.

📋 Description

• Execute clinical quality oversight activities within assigned clinical trials • Provide proactive quality management, risk-based quality oversight, and clinical trial inspection management • Support Trial Teams in embedding quality into sponsored trials and conducting quality reviews • Ensure robust service provider oversight and manage critical quality issues • Act as a Process Subject Matter Expert on quality processes, standards, and regulatory requirements • Identify, investigate, escalate, and resolve study-level quality issues, including Significant Quality Issues and Serious Breaches • Lead Inspection Hypercare Teams to maintain ongoing inspection readiness • Provide operational oversight for sponsor inspections and act as Control Room Lead or Support • Act as Inspection Lead for site inspections and conduct pre-inspection visits • Author inspection communications, including daily summaries, outcomes, and issue escalations • Coordinate inspection responses, root cause analysis, CAPA, regulatory commitments, and documentation • Support Quality Assurance audits before, during, and after audits • Collaborate with the Clinical Quality Risk Manager to operationalize quality risk management • Serve as primary clinical quality point of contact for assigned key service providers • Develop and manage service provider clinical quality agreements • Support quality-related mergers and acquisitions activities • Contribute to CQO infrastructure, process innovation, and special projects • Apply AI-driven approaches and data analytics to improve efficiency and decision-making

🎯 Requirements

• Bachelor’s or Master’s Degree or equivalent in a health care or scientific area • 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 • 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 • Ability to think strategically and objectively with digital savvy, including awareness of AI and machine learning tools • CAPA Management • Clinical Quality Management • Data Analysis • Good Clinical Practice (GCP) • Process Improvements • Project Management • Regulatory Compliance • Regulatory Inspections • Risk Management • Root Cause Identification • Strategic Thinking • Taking Initiative • US and Puerto Rico residency eligibility

🏖️ Benefits

• Annual bonus and long-term incentive, if applicable • Medical, dental, vision healthcare and other insurance benefits for employee and family • Retirement benefits, including 401(k) • Paid holidays • Vacation • Compassionate and sick days • Remote work arrangement • 25% travel allowance/requirement