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Job Description

General Summary:

The Quality Control Manager provides oversight of a variety of analytical functions that occur in the QC department supporting validation, testing and reporting of in-process, release and stability samples. This role also ensures activities occur in an efficient and cGMP compliant manner.

Key Duties and Responsibilities:

• Serves as QC representative in cross-functional, cross-departmental working teams and/or working with outside vendors to meet all laboratory needs
• Manages various laboratory program(s)/processes within the department and serves as subject matter expert (SME)
• Coordinates and facilities laboratory activities to meet commitments on-time
• Leads planning, coordination and/or review of method validations, method transfers and/or equipment qualification/requalification
• Assist in troubleshooting of analytical methods and/or equipment as required
• Authors, reviews, and/or approve data, SOPs, COAs, analytical methods, protocols and reports
• Monitors, tracks, and publishes lab metrics
• Ensures all laboratory records adhere to cGMP/GDP expectations
• Leads compliance related 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

Knowledge and Skills:

• Strong knowledge of UK and EU cGMP regulations/guidance and some experience with regulatory agency inspections
• Strong knowledge of analytical methodologies such as chromatography, flow cytometry, viable cell counting, cell-based potency assays, endotoxin, sterility, mycoplasma and qPCRs assays.
• 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.
• Extensive experience in pharmaceutical/biopharmaceutical industry, or the equivalent combination of education and experience

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

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 ApplicationAssistance@vrtx.com