Overview
Quality Control Manager – Cell Therapies Jobs in Boston, Massachusetts, USA at Vertex Pharmaceuticals
Job Description
The Manager, Quality Control 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. Wed – Sat (10-hour 4 day work week) first shift.
Key Duties & Responsibilities
Coordinates and facilitates laboratory activities to meet commitments on-time.
Ensures assay readiness with adequate inventory of qualified reagents and trained analysts.
Maintains QC lab in audit ready state with an eye on continuous improvement.
Leads planning, coordination and/or review of method validations, method transfers and/or equipment qualification/requalification.
Assists in troubleshooting of analytical methods and/or equipment as required.
Authors, reviews, and/or approves data, SOPs, COAs, analytical methods, protocols and reports.
Monitors, tracks and publishes lab metrics.
May be required to lead OOS/OOT investigations/deviations and to identify corrective actions to prevent re-occurrence.
Required Knowledge/Skills
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.
Education and **
Bachelors Degree in science or related discipline with 8+ years of experience in pharmaceutical/biopharmaceutical industry, or the equivalent combination of education and experience.
Previous managerial experience (people leader) in a QC or equivalent laboratory setting.
Flex *
On-Site Designated
Flex Eligibility ****
In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.
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 persons 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 Talent Acquisition at A
J-18808-Ljbffr
Title: Quality Control Manager – Cell Therapies
Company: Vertex Pharmaceuticals
Location: Boston, Massachusetts, USA
Category: Quality Assurance – QA/QC, Healthcare
