Job Description
Job Description
The Clinical Quality Management Associate Directoris 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 knowledgein 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
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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.
Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.