Technical Quality Control Senior Manager - Casgevy

Job Description

General Summary:

This QC position will work with external CDMOs and QC labs ensuring adherence to compliance while streamlining the commercial release of a genetically edited cell therapy product. The position will provide technical and compliance support to commercial QC operations.

This person will oversee quality control testing related to GMP release and stability as well as lifecycle improvement for methods related to raw material, in-process, release, stability testing.  The GMP-facing nature of this work requires keen attention to detail, understanding of analytical commercial compliance expectations, and knowledge of regulatory guidance for commercial stage products.  This position is a hybrid position based in London, UK, that requires the ability to work independently while actively communicating key risks to management.

Key Duties and Responsibilities:

• Acts as the lead point of contact for QC activities occurring at one or more contract manufacturing and test organizations, including release & stability testing, equipment/software validation, and adherence to project timelines.
• Manages QC operations for a gene edited hemoglobinopathy cell therapy product and helps troubleshoot technical aspects of analytical methods related to the release of biologics and cell therapy product.
• Manages commercial reference standards and assay controls programs to ensure compliance and continuity of supply to meet commercial demands.
• Assists in troubleshooting of analytical methods and/or equipment as required.
• Authors, reviews, or approves data, SOPs, COAs, analytical methods, protocols, and reports.
• Ensures all external laboratory records adhere to cGMP/GDP expectations.
• Leads compliance related teams working towards the goal of continuous improvement.

• Leads OOS/OOT investigations/deviations and assists with identification of corrective actions to prevent reoccurrence

Knowledge and Skills:

• Strong knowledge of US and EU cGMP regulations/guidance and some experience with regulatory agency inspections
• Demonstrated experience in several of the following quality related processes: batch release, OOS/OOT investigations, reference standards/assay controls, stability studies, LIMS, and raw materials testing
• Effective communication skills, both verbal and written
• Laboratory experience with assays related to the release of biologics or cell and gene therapies

• Working knowledge of common compendial assays and safety testing for GMP drug products

Education and Experience:

• Bachelor's Degree in science or related discipline is required.
• Typically requires 8 years of experience in pharmaceutical/biopharmaceutical industry, or the equivalent combination of education and experience

• Experience managing GMP external contract test labs

At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Flex Designation:

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.

#LI-Hybrid  

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]