Clinical Quality Management Associate Director - Paddington, United Kingdom - Vertex Pharmaceuticals

Vertex Pharmaceuticals

Verified Company

Paddington, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

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Description

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 crossfunctional projects of high complexity with crossfunctional team members and represent Clinical Quality Management on other largescale projects/initiatives as related to inspection readiness, preparation and conduct
Lead projects in support of GCO infrastructure and assist with departmentwide 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:

Indepth 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 fastpaced environment
Possess strong critical thinking skills
Experience managing clinical quality activities and indepth knowledge of clinical operations
Exhibits ability to multitask 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 nondiscrimination 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.