Quality Assurance Operations Manager Cell and Genetic Therapies Paddington, England
Vertex Pharmaceuticals
Full Time
Paddington, England
54456 - 73027 GBP ANNUAL Today
Job description
Job Description
General Summary:
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 of manufacturing operations, analytical laboratory operations and materials management 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 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.
- Provide QA support of change controls, process and OOS investigations, and associated CAPAs.
- Responsible for approval of COAs and product labelling.
- Provide production floor support and guidance for GMP product quality impact assessments.
- Review and approval of manufacturing documents such as technical and analytical protocols/reports
- Support GMP release of incoming raw material and components.
- Support equipment calibration activities and preventive maintenance programs.
- Responsible for identifying compliance risks and gaps for GMP 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
- 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 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.
- Critical Thinking and Problem Solving skills
Education and Experience:
- Bachelor's degree in a biotech/ Lifesciences field.
- Preferred Master's degree or relevant comparable background.
- Relevant industry experience such as manufacturing, quality assurance, and/or quality control in biotechnology/regulated pharmaceutical environment.
#LI-JM2
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].
Vertex Pharmaceuticals
www.vrtx.com
Boston, United States
Reshma Kewalramani
$5 to $10 billion (USD)
1001 to 5000 Employees
Company - Public
Biotech & Pharmaceuticals
1989
