Manager, Quality Control

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.

This position is for second shift Wednesday to Saturday 2pm - 12am

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 facilitates 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... For full info follow application link.

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 Human Resources at ApplicationAssistance@vrtx.com.