Data Review Supervisor
This role manages the data review function of Release and Stability Laboratory department supporting validation, testing and reporting of in-process, release and stability samples. Specific assigned persons are responsible for the supervision of other RSL personnel, optimizing Department resource allocation according to project/program needs to assure testing activities occur in an efficient and cGMP compliant manner while fostering the Vertex vision and values.
- Coordinate laboratory testing review activities to ensure completion in a timely manner.
- Prioritizes resources appropriately to meet commitments on time.
- Ensure direct report lab personnel have adequate training, education, and experience to perform their GMP related job function effectively.
- Provides guidance to direct reports when issues arise
- Maintains and monitors related data review metrics to identify areas of focus to increase right first time
- Provides developmental feedback and coaching to direct reports to create a collaborative environment that attracts, develop and retains personnel.
- Participates in compliance related teams working towards the goal of continuous improvement.
- Authors and reviews data, SOPs, analytical methods, protocols and reports.
- May author OOS/OOT investigations and laboratory deviations.
- Minimum Qualifications
- A minimum of a Bachelor Degree in science or related discipline is required.
- 5+ years of experience in pharmaceutical/biopharmaceutical industry with 0-2 years of supervisory responsibility.
- Basic knowledge of US and EU cGMP regulations/guidance.
- General knowledge of analytical methodologies such as chromatography, dissolution, and Karl Fisher.
- Strong attention to detail.
- Effective communication skills, both verbal and written.
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.