Job Description
General Summary:
The GMP Operational Quality Senior Specialist Cell and Gene supports the principles and application of quality assurance and regulatory compliance. The incumbent supports or executes a wide range of straightforward activities, and supports new/existing project initiatives.
Key Duties and Responsibilities:
- Supports quality oversight for root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified.
- Supports change control assessments, implementation and closure
- Identifies and facilitates continuous improvement efforts
- Supports drafting and revising Quality Agreements between CMOs/Suppliers and Vertex, as needed
- Helps represents Vertex Quality on cross-functional working teams, applying strong communication and collaboration skills.
- Support continuous improvement projects
Knowledge and Skills:
- Experience supporting multiple projects/teams within stated objectives and timelines
- Experience supporting cross-functional team members and collaborate effectively
- Good communication skills (written and verbal) and the ability to exchange potentially complex information
- Able to integrates activities with other groups, departments and project teams as needed
- Demonstrated ability to support evaluation of quality matters and solve straightforward problems using technical experience and judgement based on precedent
- Ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives
- Expanded conceptual knowledge of cGMP's in a pharmaceutical setting
- Proficient in leading event investigations, Root Cause Analysis (RCA), and CAPA
Education and Experience:
- Bachelor's degree in scientific or allied health field (or equivalent degree)
- Typically requires 2 years of experience, or the equivalent combination of education and experience
On-Site designated role, you will work five days per week on-site with ad hoc flexibility.
#LI-Onsite #ND-2
Flex Designation:
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.
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.
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 [email protected]
What We Do
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 3,500 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.
