Clinical Quality Management Associate Director
1 week ago
Job Description
The Clinical Quality Management Associate Director is responsible for leading areas of process, training, inspection, and/or compliance that support the overall Global Clinical Operations business processes and systems to drive effectiveness, standardization and improved productivity.
Key Responsibilities:
- Responsible for managing activities related to safety document management, audit and inspection readiness, quality event management, and/or process management. (Inspection Excellence)- Lead cross-functional projects of high complexity with cross-functional team members and represent Clinical Quality Management on other large-scale projects/initiatives as related to inspection readiness, preparation and conduct- Lead projects in support of GCO infrastructure and assist with department-wide decisions- Support GCO teams to troubleshoot complex issues with regards to international regulatory requirements.- Oversee management of technical tasks and is a SME in their domain- Advanced knowledge in system/technical tools and processes.- Performs other duties as assigned.
Knowledge and Skills:
- In-depth understanding of international GCP regulatory requirements, and ICH guidelines- Displays highly developed organizational technical/project leadership qualities.- Excellent verbal and written communication skills and presentation skills: ability convey complex/technical findings to varied audiences and persuade other to adopt a different point of view- Demonstrates attention to detail, accuracy, excellent review and analytical skills in a fast-paced environment- Possess strong critical thinking skills- Experience managing clinical quality activities and in-depth knowledge of clinical operations- Exhibits ability to multi-task effectively
**Education**:
Bachelor’s degree
LI-Remote
Company Information
- Vertex is a global biotechnology company that invests in scientific innovation.
- Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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