Manager, Quality Systems Cell and Gene
Vertex Pharmaceuticals Incorporated | |
United States, Massachusetts, Boston | |
50 Northern Avenue (Show on map) | |
Oct 04, 2024 | |
Job Description General Summary: The Quality Systems Manager provides technical and strategic leadership for quality systems, quality processes, and associated governance for the cell and gene therapy business unit. This position focuses not just on the "what" but the "how", ensuring phase appropriate and risk-based compliance. Key Duties and Responsibilities:
Knowledge and Skills: * Good understanding of both the conceptual and practical application of cGMPs in a pharmaceutical setting * Ability to evaluate quality matters and make decisions utilizing risk-based approach * Technical knowledge including but not limited to: risk management, quality systems, and quality governance * Proven experience leading a variety of straightforward projects/teams within stated objectives and timelines. * Solid quality culture knowledge and understanding of how to influence and improve overall compliance * Strong communication skills (written and verbal) with the ability to communicate to a variety of audiences. * Experience with electronic document management systems (e.g., Trackwise, Veeva) Education and Experience:
Flex Designation: Hybrid-Eligible Or On-Site EligibleFlex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 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 ApplicationAssistance@vrtx.com |