Job Description
Director, GDP Operational Quality VCGT page is loaded
Director, GDP Operational Quality VCGT
Apply locations Paddington, United Kingdom time type Full time posted on Posted Yesterday job requisition id REQ-17991Job Description
T he GDP Director is responsible for oversight of department activities, development of personnel and ensuring quality of deliverables within their purview . This role is recognized as a technical resource in the principles and application of quality assurance and GDP .
The successful applicant will perform quality risk assessments and assist with completion of quality agreements, provide operational support for commercial Cell and Gene Therapy medicinal products distribution, working closely with the ATC Quality Operations team and Supply Chain team in qualifying distributors and transportation companies .
The Director will complete the execution of the quality Risk M anagement P lans that will govern the monitoring and oversight by QA and business functions, working closely with the business stakeholders and the functions within the Quality organization with the objective of ensuring transparency for gaining insights regarding operational risks and mitigations.
This individual is expected to demonstrate success in engaging teams and stakeholders for collaboration in advancing quality outcomes and operational excellence through business and Quality.
This role will be hybrid, but with travel and some office presence and responsibilities necessary .
KEY RESPONSIBILITIES:
The position is responsible to ensure the successful execution, but is not limited to the following:
E stablish robust Quality Processes/Process Ownership for the distribution of Cell and Gene Therapy Commercial & Clinical Finished Goods and for the distribution of apheresis material , ATMP critical components .
Responsible for the Quality oversight and management of Cell and Gene Therapy curriers/transportation companies and distributors: creating and maintaining Quality Agreements, developing KPIs and establishing Quality meetings
Develop and manage an effective global shipping qualification process.
Participate in Geographic Expansion activities to ensure that Quality related actions are planned into projects and completed in line with the commitments
Support Recalls, mock recalls and any other on-market activity
Act as QA assessor/approver on Change Controls: resolve gaps, approve change plans, classifications, strategy for GDP/GMP actions.
Develop, utilize, and continue to mature tools to ensure efficiency in execution
Support initiatives associate d 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 associate d forms.
KEY REQUIREMENTS :
Bachelor’s Science degree or equivalent degree
Quality Assurance experience in cell and gene therapy products in a biotech/pharma or healthcare setting
Thorough understanding on MHRA and EMA regulatory framework for Cell and Gene Therapy medicinal products, and able to navigate industry developments and providing key strategic guidance to the business
A real subject matter expert on all aspects related to GMP and GDP within Pharmaceutical distribution
Ability to collaborate with cross-functional teams
Extensive e xperience conducting investigations, performing Root Cause Analysis, and identifying CAPA.
#LI-Hybrid
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 ApplicationAssistance@vrtx.com.
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Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has multiple approved medicines that treat the underlying cause of cystic fibrosis (CF) — a rare, life-threatening genetic disease — and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust pipeline of investigational small molecule, cell and genetic therapies in other serious diseases where it has deep insight into causal human biology, including sickle cell disease, beta thalassemia, APOL1-mediated kidney disease, pain, type 1 diabetes, alpha-1 antitrypsin deficiency and Duchenne muscular dystrophy.
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