Clinical Quality Operations Manager (Remote)

Merck KGaA Darmstadt Germany - Rahway, NJ

Full-time - Mid Level

Remote - Rahway, NJ

Chemical Manufacturing

About the position

The Clinical Quality Operations Manager (CQOM) at Merck is responsible for ensuring high-quality data from clinical trials by overseeing operational quality management and inspection activities within a designated therapeutic area. This role involves developing quality plans, managing vendor oversight, and ensuring compliance with regulatory standards. The CQOM collaborates with clinical trial teams to embed quality into trials and prepares for regulatory inspections, maintaining ongoing inspection readiness.

Responsibilities

• Develop Risk Assessment and Categorization Tools and Quality Plans in partnership with the Clinical Trial Team (CTT).
• Perform quarterly Therapeutic Area (TA) level reviews of quality plans and risk mitigation approaches.
• Ensure comprehensive oversight of all activities delegated to third parties, including vendor oversight and quality agreements.
• Facilitate and oversee responses to audit and inspection observations.
• Analyze data across therapy areas to identify signals and trends and implement process improvement strategies.
• Develop skill sets to recognize and respond to new and emerging risks using technology.
• Build effective working relationships with key stakeholders to ensure role clarity and business effectiveness.
• Contribute to the standardization of Clinical Quality Operations procedures, tools, and templates.

Requirements

• Experience in clinical quality operations or related field is preferred but not mandatory.
• Strong understanding of Good Clinical Practice (GCP) and regulatory inspection processes.
• Ability to develop and implement quality plans and risk assessment tools.
• Excellent communication and relationship-building skills.

Nice-to-haves

• Experience with digital data management in clinical trials.
• Familiarity with regulatory agencies such as FDA, EMA, and others.

Benefits

• Health insurance
• 401k plan
• Paid holidays
• Flexible scheduling
• Professional development opportunities