Quality Assurance Operational Manager, 12-month contract
Vertex Pharmaceuticals
Type of Role: Contract position, Inside IR35
Location: Hybrid, 3 days on site in Paddington, London.
Department: Operational Area Quality
Looking for opportunities with purpose, impact and possibilities? Our client, Vertex, is a global biotechnology company that invests in scientific innovation. As they grow their pipeline at pace, they are strengthening their reputation for creating transformative medicines for people with serious diseases.
The Quality Assurance Operational Manager is recognized as an expert internally in the principles and application of quality assurance and compliance.
The Quality Assurance Operational Manager will provide QA support for manufacturing operations for the 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 and Responsibilities:
* 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.
* Provide QA support for change controls, process and OOS investigations, and associated CAPAs related to batch records and manufacturing.
* Responsible for approval of COAs and product labelling.
* Provide manufacturing support and guidance for GMP product quality impact assessments.
* Review and approval of manufacturing documents.
* Support GMP release of incoming raw material and components.
* Responsible for identifying compliance risks and gaps for GMP batch record processes.
* 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 monthly/quarterly 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.
Knowledge and Skills:
* Demonstrated experience providing QA support to GMP manufacturing operation.
* Must have experience with batch record review and batch release.
* 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.
* Knowledge in 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.
* Critical Thinking and Problem-Solving skills.
Vertex is partnering with Talent Works to manage their international temporary job openings. If you are successful in your application, you will be employed by Talent Works to work on a temporary assignment at Vertex.