Quality Control Manager - Cell Therapies

The Manager, Quality Control is a key position that provides oversight of a variety of analytical functions in the QC department supporting testing and reporting of in-process, release, and stability samples. This role ensures activities occur efficiently and in a cGMP compliant manner and has formal people management responsibilities.

• Manages various laboratory programs/processes (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 facilitates laboratory activities to meet commitments on‑time.
• Ensures lab personnel have appropriate training.
• Assists in troubleshooting analytical methods and/or equipment as required.
• Authors, reviews, and approves data and SOPs.
• Monitors, tracks, and publishes lab metrics.
• Ensures all laboratory records adhere to cGMP/GDP expectations.
• Leads sub‑teams working toward continuous improvement.
• May lead OOS/OOT investigations/deviations and identify corrective actions to prevent recurrence.
• Provides guidance to reports when issues arise and coaches and develops reports.
• Serves as T1D Cell QC representative in cross‑functional, cross‑departmental teams and in working with outside vendors to meet all laboratory needs.

• Strong knowledge of U.S. and EU cGMP regulations/guidance and experience with regulatory agency inspections.
• Strong knowledge of analytical methodologies such as flow cytometry, cell‑based assays, qPCR, ELISA, BACT, endotoxin, and application/interpretation of GMP requirements.
• Effective verbal and written communication skills.
• Ability to prioritize multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail.

• Bachelor’s Degree in science or a related discipline plus 8 years of experience in the pharmaceutical/biopharmaceutical industry, or the equivalent combination of education and experience.

Schedule:

Sunday – Wednesday, 7:30 am – 6:00 pm.

$117,800 – $176,800.

The range provided is based on a reasonable estimate for the base salary at the time of posting. This role is eligible for an annual bonus and equity awards and may also be eligible for overtime pay in accordance with federal and state requirements. Actual base salary will be based on factors such as skills, competencies, experience, and other job‑related factors permitted by law.

On‑Site Designated.

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 at Vertex Program and may be changed at any time.

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 and will make reasonable accommodations for qualified individuals with known disabilities.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position should make a request to the recruiter or hiring manager or contact Talent Acquisition at A