Quality Control Manager - Cell Therapies

Vertex Inc.•Boston, MA

8d•$117,800 - $176,800•Onsite

About The Position

The Manager, Quality Control is a key position that provides oversight of a variety of analytical functions that occur in the QC department 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 will have formal people management responsibilities.

Requirements

Strong 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-based assays, qPCR, ELISA, BACT, endotoxin 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.

Responsibilities

Manages various laboratory program(s)/processes within the department (assay readiness, training, sample management, data review and reporting) and serves as QC representation at triage and QC of contact for Quality Events.
Coordinates and facilities laboratory activities to meet commitments on-time
Ensure lab personnel have appropriate training.
Assist in troubleshooting of analytical methods and/or equipment as required
Authors, review, and/or approves data, SOPs,
Assist in monitor, tracking and publishing lab metrics
Ensure 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
Provide guidance to reports when issues arise.
Coach and develop reports.
Serves as T1D Cell QC presentative in cross-functional, cross-departmental working teams and/or working with outside vendors to meet all laboratory needs