Senior Manager, Quality Operations Cell and Gene (Hybrid)
Company: Vertex Pharmaceuticals
Location: Boston
Posted on: October 8, 2024
Job Description:
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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Keywords: Vertex Pharmaceuticals, Salem , Senior Manager, Quality Operations Cell and Gene (Hybrid), Executive , Boston, Massachusetts
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