Description

Job Description

General/Position Summary

The GMP Quality Operations Manager is recognized as an expert internally in the principles and application of quality assurance and compliance. The Quality Manager will provide QA support of manufacturing operations for the external manufacture of Cell & Genetic Therapeutic programs. This role will drive, 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

• Responsible for quality support of Vertex Cell and Gene Therapy manufacturing operations across all phases of development, support of analytical laboratory, materials management and manufacturing operations.
• Responsible for GMP batch disposition activities in compliance with EU GMP, FDA, ICH, and other applicable regulations, 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 and archiving activities
• Ensure timely and compliant batch review, batch disposition documentation
• Support routine investigation, CAPA, Change controls
• Partner with External CDMOs located in Netherlands and other EU locations
• Provide QA support of change controls, process and OOS investigations, and associated CAPAs.
• Responsible for identifying compliance risks and gaps for GMP processes and supporting implementation of mitigating controls
• Support audit and inspection readiness activities.
• Act as a trusted advisor by providing compliance guidance through collaborative review and partnering with business stakeholders and contract manufacturers.
• Assist with addressing product complaints
• Maintain periodic batch record metrics and assists department with routine/quarterly Quality System data review metrics and reporting
• Lead and participate in Cell & Genetic Program and Quality projects and drive continuous improvement activities.

Required Knowledge/Skills

• Bachelor's degree in a biotech/ Lifesciences field.
• Strong QA experience in a GMP-regulated environment
• Hands-on experience with ATMPs (cell therapy, gene therapy, tissue-engineered products) strongly preferred or with Biologicals/sterile
• Strong knowledge of EU GMP Part IV (ATMP), Annex 1, and GxP principles
• Demonstrated experience providing QA support to GMP manufacturing operation
• Experience with network-based applications such as Oracle, TrackWise, Veeva
• Familiarity with aseptic processing, viral vectors, cell processing, or cryopreservation
• Ability to evaluate quality matters, strong problem solving and make decisions utilizing risk-based approach
• Ability to work in fast-paced, evolving ATMP environments
• Proven experience leading a variety of projects/teams within stated objectives and timelines
• Ability to manage own workload to achieve goals and seek opportunities to share information and help others understand technical processes
• Strong communication skills (written and verbal) with the ability to communicate effectively with cross functional team members, exchanging complex information and influencing/guiding others to understand a stated viewpoint

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