Country Clinical Quality Manager

🔥 6 minutes ago

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $142.4k - $224.1k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🏥 Clinical Operations

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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

• Oversee all Clinical Quality Management activities in the respective country/cluster • Implement local and global processes and procedures • Identify process improvement opportunities and support continuous improvement initiatives • Support audits, inspections, Quality Control activities, and local training • Act as local expert for ICH-GCP and local regulations, including assessing impacts of new or updated regulations • Manage the local network of process owners and Subject Matter Experts • Ensure regular updates of local SOPs and Work Instructions • Lead country-level continuous quality improvement activities and support global/regional initiatives • Coordinate local training needs and support local training delivery • Coordinate and oversee Quality Control activities, including IHQCP, QCVs, and QC checks • Perform QC activities and ad hoc site visits when requested • Identify trends, conduct root-cause analyses, and develop local action plans • Serve as primary local contact for Quality Assurance and regulatory agencies • Manage audit and inspection preparation, ongoing activities, and follow-up • Track CAPAs and coordinate responses to audit and inspection reports • Escalate quality, compliance, privacy, and serious breach issues and support investigations • Evaluate and coordinate investigations related to clinical supply GCP inquiries and incorrect clinical supply management • Lead local supplier qualifications and re-qualifications and support supplier quality issue resolution • Support Quality Management System assessments for suppliers • Support local compliance and privacy initiatives and reporting • Support global and regional key initiatives and projects

🎯 Requirements

• Bachelor's Degree or equivalent in relevant health care area • 6+ years of relevant experience in clinical research, including direct field monitoring experience or management/oversight of such individuals • Experience in Country Operations preferred • Deep knowledge of clinical trial processes, Good Clinical Practice (GCP), and other clinical research regulations • Track record of initiating, planning, and delivering projects • Knowledge of project management practices • Experience leading cross-functional teams • Clinical Quality Management experience ideally including Quality Control Activities, Process Management & Improvement • Experience managing audits and inspections ideally • Experience coordinating and delivering training sessions ideally • Superior oral and written communication and leadership skills • Excellent project management, organizational, and prioritization skills • Excellent teamwork and conflict resolution skills • Ability to analyze, interpret, and solve complex problems • Strategic, objective, creative, and innovative thinking • Ability to interact with all levels of clinical research management and exert influence to achieve results • Expertise in ICH-GCP and local regulations • No visa sponsorship available • US and Puerto Rico residents only

🏖️ Benefits

• Annual bonus • Long-term incentive, if applicable • Medical, dental, and vision healthcare • Other insurance benefits for employee and family • Retirement benefits, including 401(k) • Paid holidays • Vacation • Compassionate and sick days • Remote work arrangement