Description

Job Description

Job Summary

The Sr. Quality Specialist is recognized as an expert internally in the principles and application of quality assurance and compliance. The Senior Quality Specialist will provide QA support of manufacturing operations, analytical laboratory operations and materials management for the external Cell & Genetic Therapeutic programs. This role will review & support activities related to product disposition including review of batch data, batch records, deviations, in-process data, EM data, QC release testing and other quality systems documentation.

Key Duties & Responsibilities

• Supports for quality oversight of Vertex Cell and Gene Therapy manufacturing operations across all phases of development and commercial, support of analytical laboratory, materials management, and facility/engineering groups.
• Responsible for GMP batch disposition activities including review and approval of batch records, deviations, in-process data, EM data, QC release testing, materials review board and other quality activities as applicable to determine acceptability of product disposition.
• Support QA execution of process and OOS investigations, and associated CAPAs.
• Responsible for approval of COAs and product labelling.
• Provide manufacturing support and guidance for GMP product quality impact assessments at the Contract Manufacturers.
• Support GMP release of incoming raw material and components.
• Participates and supports in compliance activities and help drive the closure of any observations by partnering with Vertex Compliance and Quality Assurance for CDMO and CTO activities.
• Responsible for identifying compliance risks and gaps for GMP processes.
• Record and maintain daily/monthly/quarterly batch record metrics and assists department with required Quality System data review metrics and reporting
• Support Cell & Genetic Program and Quality projects including Quality system, protocol and test data review and manufacturing process/SOP improvements.

Required Education Level

• Bachelor's degree in a biotech/ Lifesciences field.

Required Knowledge/Skills

• Demonstrated experience providing QA support and oversight of GMP manufacturing operation in Cell & Gene manufacturing.
• Experience successfully leading event investigations, Root Cause Analysis and CAPA
• Experience with network-based applications such as Oracle, TrackWise, Veeva
• Understanding of regulatory environment including quality systems and compliance.
• Professional membership or equivalent in relevant societies, network of knowledge in cell and gene therapy industry.
• Ability to evaluate quality matters and make decisions utilizing risk-based approach
• Ability to independently lead cross-functional teams, and effectively communicate with business stakeholders.
• Critical Thinking and Problem Solving skills

Flex Designation:
Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: 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-Hybrid

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