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Executive Director, Centralized Monitoring and Quality Assurance
hace 2 meses
**Job Summary**
We are seeking an experienced Executive Director to lead our Centralized Monitoring team at Thermo Fisher Scientific. As a key member of our organization, you will be responsible for providing operational and strategic leadership for the development and delivery of Risk Based Quality Management (RBQM) strategy and centralized monitoring objectives.
**Key Responsibilities**
- Provide subject matter expertise in Risk Based Quality Management (RBQM) methodologies, tools, processes, and central monitoring methods.
- Develop and manage client and partner relationships, mentoring and directing staff and management, including overseeing and ensuring quality of RBQM and data strategy at the project and program level.
- Drive risk assessment and define mitigations and proper monitoring strategy for critical data and processes.
- Drive policy development and support implementation of broader goals by working across departments.
- Supervise and coordinate centralized monitoring client risk and data strategy delivery.
- Ensure the CM teams are provided with the necessary support and resources.
- Manage staff and management, including interviewing, professional development, and performance management.
- Lead internal and cross-functional initiatives, including process and tool development.
- Contribute to future strategy and vision for CM and Clinical Operations.
**Requirements**
- Knowledge of broad drug development process and expertise in cross-functional adoption of Risk Based Quality Management.
- Knowledge of industry regulatory and clinical standards such as ICH E6 & E8.
- 15+ years of previous experience within Pharma or CRO organizations, providing the knowledge, skills, and abilities to perform the job.
**About Us**
Thermo Fisher Scientific is an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies.