Vertex Pharmaceuticals
Senior Manager, Quality Operations Cell and Gene (Hybrid)
Vertex Pharmaceuticals, Boston, Massachusetts, us, 02298
Senior Manager, Quality Operations Cell and Gene (Hybrid)Job Description
General/Position Summary
The Quality Assurance Senior Operational Manager is recognized as an expert internally in the principles and application of quality assurance and compliance. The Quality Snr Manager will provide QA support of manufacturing operations, analytical laboratory operations and materials management 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 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.
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 approval of COAs and product labeling.
Review and approval of manufacturing documents such as technical and analytical protocols/reports.
Support technical transfer, and Process Performance qualification activities.
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.
Support the vendor management process including the creation and review of Quality Agreements with suppliers.
Assist with addressing product complaints.
Maintain periodic batch record metrics and assist 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.
Demonstrated experience providing QA support to GMP manufacturing operation.
Experience successfully leading event investigations, Root Cause Analysis and CAPA.
Experience with network-based applications such as Oracle, TrackWise, Veeva.
In-depth knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; Biotec/Cell & Gene GMP regulations and applicability (e.g. EU, FDA, ICH, USP, etc. or other industry best practices ex. ISPE, WHO, etc.).
Knowledge in AAV/Cell technology, aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish and testing.
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.
Ability to travel to our CDMO partners on site in Europe, up to 40% travel may be required.
Flex Designation:
Hybrid-Eligible Or On-Site Eligible
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.
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General/Position Summary
The Quality Assurance Senior Operational Manager is recognized as an expert internally in the principles and application of quality assurance and compliance. The Quality Snr Manager will provide QA support of manufacturing operations, analytical laboratory operations and materials management 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 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.
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 approval of COAs and product labeling.
Review and approval of manufacturing documents such as technical and analytical protocols/reports.
Support technical transfer, and Process Performance qualification activities.
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.
Support the vendor management process including the creation and review of Quality Agreements with suppliers.
Assist with addressing product complaints.
Maintain periodic batch record metrics and assist 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.
Demonstrated experience providing QA support to GMP manufacturing operation.
Experience successfully leading event investigations, Root Cause Analysis and CAPA.
Experience with network-based applications such as Oracle, TrackWise, Veeva.
In-depth knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; Biotec/Cell & Gene GMP regulations and applicability (e.g. EU, FDA, ICH, USP, etc. or other industry best practices ex. ISPE, WHO, etc.).
Knowledge in AAV/Cell technology, aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish and testing.
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.
Ability to travel to our CDMO partners on site in Europe, up to 40% travel may be required.
Flex Designation:
Hybrid-Eligible Or On-Site Eligible
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.
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