Job Description

General Summary:

The Manager, Quality Control is a key position that provides oversight of a variety of analytical functions that occur across the Vertex Manufacturing Center (VMC) and Leiden Center (LC1) supporting testing, and reporting of in-process, release, and stability samples. This role also ensures activities occur in an efficient and cGMP compliant manner. The role is a third shift position, Wednesday through Saturday, and will have formal people management responsibilities. 

Work shift: Wednesday to Saturday, night shift between the hours of 9:00pm to 9:00am

Key Duties and Responsibilities:

• Independently manages a variety of laboratory program(s)/processes within the department (assay readiness, training, sample management, data review and reporting and serves as Quality Control representation at triage and Quality Control contact for Quality Events.
• Coordinates and facilities laboratory activities to meet commitments on time
• Ensures lab personnel have appropriate training.
• Assists in troubleshooting of analytical methods and/or equipment as required
• Authors, review, and/or approves data, SOPs,
• Assists in monitoring, tracking and publishing lab metrics
• Ensures all laboratory records adhere to cGMP/GDP expectations
• Leads sub-teams working towards the goal of continuous improvement
• May be required to lead OOS/OOT investigations/deviations and to identify corrective actions to prevent reoccurrence
• Provides guidance to reports when issues arise. Coach and develop reports.
• Serves as the Quality Control representative in cross-functional, cross-departmental working teams and/or working with outside vendors to meet all laboratory needs. 

Knowledge and Skills:

• Prior QC management experience
• Knowledge of US and EU cGMP regulations/guidance and some experience with regulatory agency inspections
• Strong knowledge of analytical methodologies such as flow cytometry, cell counts and viability (NC-200), sterility (BACT), endotoxin, cell culture and applying/interpretation of GMP requirements.
• Effective communication skills, both verbal and written
• Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail

Education and Experience:

• Bachelor’s degree in science or related discipline is required with 8 years of experience in pharmaceutical/biopharmaceutical industry, or the equivalent combination of education and experience.

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.

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this On-Site designated role, you will 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.

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