This job is closed
We regret to inform you that the job you were interested in has been closed. Although this specific position is no longer available, we encourage you to continue exploring other opportunities on our job board.
Clinical Quality Operations Manager (Remote)
Merck KGaA Darmstadt Germany - Springfield, IL
posted 2 months ago
About the position
The Clinical Quality Operations Manager (CQOM) at Merck is responsible for overseeing operational quality activities within assigned therapeutic areas, ensuring high-quality data from clinical trials. This role involves managing inspection readiness, developing quality plans, and ensuring compliance with regulatory standards. The CQOM collaborates with clinical trial teams to embed quality into trials, oversee vendor management, and address quality issues proactively. The position requires a strategic approach to quality management and the ability to lead cross-functional teams in a global environment.
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 activities delegated to third parties, including vendor oversight and quality agreements.
- Facilitate responses to audit and inspection observations and analyze data to identify trends for process improvement.
- Develop skill sets to recognize and respond to new risks using technology, particularly in 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).
- Ensure timely implementation of actions related to audits and inspections, tracking CAPA and regulatory commitments.
Requirements
- Minimum of 6 years of relevant experience in clinical research, including at least 2 years in 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 is desirable.
- Master's degree preferred.
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
