Job Description
The GMP Operational Quality Manager is responsible for the management and oversight of the QA batch disposition process. The role will lead QA execution activities for the review, applicable disposition and archiving of batches associated with Cell & Genetic (C&G) Therapeutic programs including review of batch data, batch records, deviations, in-process data, EM data, QC release testing and other quality systems documentation.
A key expectation is the ability to closely collaborate and build relationships with internal and external stakeholders to drive compliance and continuous improvement activities.
Key Duties & Responsibilities
Responsible for quality disposition execution of Cell and Gene (C&G) Therapy batches manufactured externally across clinical, launch and commercial processes including support of analytical laboratory, and manufacturing operations.
Responsible for GMP batch disposition activities including review and approval of batch records, deviations, in-process data, EM data, QC release testing, and other quality activities as applicable to determine acceptability of product disposition.
Review of QA disposition change controls, process and OOS investigations, and associated CAPAs.
Responsible for approval of COAs and product labelling.
Support technical transfer, and Process Performance qualification batch review and disposition activities.
Responsible for identifying compliance risks/gaps for GMP disposition processes implementation of mitigating controls.
Assist with addressing product complaints investigations related to batches.
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 as determined by Management.
Required Education Level
Master's/Bachelor's degree in a biotech/ Lifesciences field.
Required Experience
Extensive relevant industry experience such as operational quality assurance, and/or quality control in biotechnology/regulated pharmaceutical environment.
Required Knowledge/Skills
Extensive Batch Release experience
Project Management experience
Demonstrated experience providing QA operational support
Experience successfully leading event investigations, Root Cause Analysis and CAPA
Experience with network-based applications such as Oracle, TrackWise, Veeva
Knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; Biotech/Cell & Gene GMP regulations and applicability. (e.g. EU, FDA, ICH, USP, etc. or other industry best practices ex. ISPE, WHO, etc.)
Knowledge in Cell therapy, aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish and testing
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.
Other Requirements
Indicate required certifications, licenses, or specialized trainings.
Up to 15% Travel may be required
Flex Designation:
Hybrid-Eligible Or On-Site EligibleFlex 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 [email protected]
