Technical Quality Control Senior Manager - Casgevy

Technical Quality Control Senior Manager - Casgevy

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: 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.

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.

About Vertex

Help Us Achieve Our Mission

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia, acute pain and acromegaly, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including IgA nephropathy, neuropathic pain, APOL1-mediated kidney disease, primary membranous nephropathy, congenital adrenal hyperplasia, ACTH-dependent Cushing's syndrome, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type 1.

Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 16 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube, and X

We believe our culture is one of Vertex’s greatest strengths and a key enabler of our ability to deliver transformative medicines for patients who need them. Rooted in innovation, purpose and collaboration, our culture empowers people to take smart risks, challenge conventional thinking and do their best work. The diversity of our people is central to that culture. By bringing together individuals with different backgrounds, experiences and perspectives, we foster an environment where new ideas thrive, better decisions are made and breakthrough innovation is possible. We are committed to creating a workplace where everyone feels valued, included and connected to our shared mission, because we know that our unique culture and the collective strength of our people are what set Vertex apart.