Operational Quality Manager
3 weeks ago
Job Description
General Summary:
The Quality Manager will be supporting the activation of commercial gene therapy Authorised Treatment Centres.
The successful applicant will perform quality risk assessments and assist with completion of quality agreements, provide operational support for commercial site selection and activation of apheresis and cell-therapy laboratory centers. This role will be supporting the activation of the Authorized Treatment Centers (commercial sites) and will work closely with the Apheresis and Infusion Operations team and the QA Audit team in qualifying sites partnering to provide life saving cell and gene therapy to patients in need.
The successful applicant will also support with the development and maturation of quality systems necessary for the effective assessment and authorisation of Authorised Treatment Centres.
Key Duties and Responsibilities:
- Work closely with the Audit and Inspection quality function to establish the audit strategy for Auditing and Performance oversight to evaluate treatment centers ensuring compliance with standards established by applicable regulatory, licensing, and accrediting bodies
- Conduct treatment center Audits where required
- Actively engage with the Audit Management, Vender Management and Apheresis Infusion Operations functions on site qualifications
- Establish and maintain Quality Agreements
- Work with the business areas on site selection
- Provide QA support of change controls, investigations, CAPA's and effectiveness checks
- Responsible for identifying risks and communicating gaps for process/systems
- Coordinate preparation activities with SMEs
- Real-time Inspection Readiness
- Develop, utilize, and continue to mature tools to ensure efficiency in execution
- Support initiatives associated maintaining relevant inspection related history for inspection readiness purposes.
Other Activities
- Identify areas of improvement and participate in process improvement initiatives
- Additional as needed support to processes, systems, procedures to ensure continuous Quality improvement
- Additional activities as needed to support the Quality Systems
- Author/Revise Standard Operating Procedures and associated forms.
Knowledge and Skills:
- Critical Thinking / Problem Solving
- Experience successfully leading event investigations, Root Cause Analysis (RCA) and CAPA
- Knowledge of current industry trends and has the ability to use the latest technologies
- Collaboration / Teamwork / Conflict Management
- Strong communication and influencing skills
- Critical Thinking / Problem Solving
- Ability to evaluate quality matters and make decisions utilizing risk based approach
- Root Cause Analysis tools/methodology
- Knowledge of applications, such as: OPM (Oracle), QDoCCs,Trackwise/Veeva, MS Office
Education and Experience:
- Bachelor's degree or Master's degree
- Strong understanding of EU and UK regulations for tissues and cells
- Quality Assurance experience supporting apheresis, transplant, or cell-therapy lab in a biotech/pharma or healthcare setting
- Project Management Skills
- Operational QA experience with experience with the following is:
- Quality System background and understanding of the Inspection processes
- Understanding of GMP/GDPs and applicable guidelines/guidance
- Ability to collaborate with cross-functional teams
- Excellent technical writing, presentation, and communication skills
- Experience conducting investigations, performing Root Cause Analysis, and identifying CAPA.
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.
Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. 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
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