The Principal Manager, Clinical Quality Management will be a motivated individual working in a dynamic, cross-functional environment within the Global Clinical Operations team. This position will be responsible for training, process management and inspection readiness activities supporting Global Clinical Operations. This position will report directly to the Director, Clinical Quality Management.
- Develop content and deliver training on GCP topics for new hire on-boarding and ongoing training for all of Global Clinical Operations (staff ~400 people)
- Responsible for assuring quality and consistency in the information being delivered, provide direction on policies, procedures, and practices.
- Inspection Readiness
- Lead inspection readiness and inspection preparation activities for Global Clinical Operations, including SME training/preparation and back room activities, and support back room during GCP inspections.
- Represent Global Clinical Operations in internal process audits as needed
- Contribute to Global Clinical Operations audit/inspection planning, management and response generation
- Ensure consistency in processes throughout all functions in Global Clinical Operations
- Responsible for conducting lessons learned across Global Clinical Operations trials and ensure feedback is incorporated into future process improvements
- Lead Global Clinical Operations in the Development of CAPA plans and investigations in response to audits and inspections for Global Clinical Operations. Ensure inspection findings are remediated and processes are implemented within GCO.
- Bachelor of Science degree in a life sciences discipline, advanced degree preferred
- At least 7 years of relevant work experience in the biopharmaceutical industry
- Excellent understanding of GCP, CFR and ICH guidelines
- Experience managing clinical quality activities and in-depth knowledge of clinical operations
- Experience with site/process audits and regulatory inspections
- Demonstrated attention to detail, accuracy, excellent review and analytical skills in a fast-paced environment.
- Results oriented
- Significant experience with line management of employees
- Excellent leadership and interpersonal skills with an ability to effectively work and problem solve within a multidisciplinary team
- Excellent verbal and written communication and presentation skills
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases.
Founded in 1989 in Cambridge, Massachusetts, our corporate headquarters is now located in Boston's Innovation District, and our international headquarters is in London, United Kingdom. We currently employ approximately 2,500 people in the United States, Europe, Canada, Australia and Latin America with nearly two-thirds of our staff dedicated to research and development.
Vertex is consistently recognized as one of the industry's top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. Our research and medicines have also received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the French Prix Galien and the British Pharmacological Society awards. For additional information and the latest updates from the Company, please visit www.vrtx.com.
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. 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.