Manager, Quality Control
The Manager, Quality Control 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. The role will have formal people management responsibilities.
Key Duties & Responsibilities
- Coordinates and facilities 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
- Assist in troubleshooting of analytical methods and/or equipment as required
- Authors, review, and/or approves data, SOPs, COAs, analytical methods, protocols and reports
- Monitor, track and publish lab metrics
- May be required to lead OOS/OOT investigations/deviations and to identify corrective actions to prevent re-occurrence
- Bachelor's 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
- 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
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.