Quality Control Manager - Cell Therapies

Job Description

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

Key Duties and 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

Knowledge and 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 Experience:

• 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.

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

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 @ Vertex Program and may be changed at any time.

#LI-Onsite

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 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 Talent Acquisition at [email protected]