Clinical Quality Operations Manager (Remote)

$135,500 - $213,400/Yr

Merck KGaA Darmstadt Germany - Boston, MA

Full-time - Mid Level

Onsite - Boston, MA

Chemical Manufacturing

About the position

The Clinical Quality Operations Manager (CQOM) is responsible for ensuring high-quality data from clinical trials by overseeing operational quality management and inspection management activities within a specific therapeutic area. This role involves developing quality plans, managing vendor oversight, and ensuring compliance with regulatory standards. The CQOM will also prepare for and manage regulatory inspections, ensuring ongoing inspection readiness and addressing quality issues as they arise.

Responsibilities

• Develop Risk Assessment and Categorization Tools and Quality Plans in partnership with the Clinical Trial Team (CTT).
• Perform quarterly Therapeutic Area level reviews of quality plans and risk mitigation approaches.
• Ensure comprehensive oversight of activities delegated to third parties, including vendor oversight and quality agreements.
• Facilitate and oversee responses to audit and inspection observations, analyzing data to identify trends and implement process improvements.
• Develop skill sets to recognize and respond to new risks using technology, particularly in Good Clinical Practice (GCP) and digital data management.
• Build effective working relationships with key stakeholders to maintain role clarity and business effectiveness.
• Contribute to the standardization of Clinical Quality Operations procedures, tools, and templates.
• Maintain current regulatory inspection knowledge related to GCP inspections by regulatory agencies worldwide.
• Lead and support GCP inspections, monitoring and communicating key regulatory developments.
• Develop and maintain GCP inspection procedures and guidelines within Global Clinical Trial Operations (GCTO).
• Develop strategies for managing GCP inspections to ensure consistent and proactive handling of inspections.
• Maintain and QC the global inspection tracking system for GCP Regulatory Health Authority inspections.
• Act as the subject matter expert for Inspection Management, providing real-time advice and guidance.
• Develop inspection management plans for assigned Regulatory Health Authority inspections.

Requirements

• Bachelor's or equivalent in a relevant health care area; Master's degree preferred.
• Minimum of 6 years of relevant experience in clinical research, including 2 years of experience with clinical quality systems and regulatory inspections.
• Knowledge of clinical development programs and quality management systems.
• Expert knowledge of ICH-GCP and worldwide Regulatory Health Authority requirements.
• Experience with CAPA management solutions and risk management tools.
• Superior oral and written communication skills in an international environment.
• Excellent project management and organizational skills.
• Strong teamwork and leadership skills, including conflict resolution expertise.

Nice-to-haves

• Further formal education in quality management or business management.

Benefits

• Bonus eligibility
• Long term incentive if applicable
• Health care and other insurance benefits for employee and family
• Retirement benefits
• Paid holidays
• Vacation
• Sick days