Manager, Quality Control

Vertex Pharmaceuticals•Boston, MA

3d•Onsite

About The Position

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.

Requirements

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
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.

Nice To Haves

Embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends.
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.

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.