Job Description
General/Position Summary
The Director, Cell & Gene Quality, International will support defining the strategy for the international expansion of Cell & Genetic programs. The role will establish the quality risk management plans, work closely with cross-functional QA, CMC, External manufacturing, Supply Chain and Commercial teams to ensure QA oversight is maintained.
Key activities include develop, lead and direct the establishment of capabilities for Operational quality managing Cell procurement, and Infusion activities at Apheresis and Infusion centers across Cell & Gene programs.
The role will closely partner with operational stakeholders to lead/support the development and execution of quality projects, quality & technical risk management including execution of associated mitigation plans, and to participate in Cell & Genetic therapies projects and governance committees for EU expansion.
This role will help build the EU/International QA compliance Apheresis expertise that supports Clinical and Commercial C&G Programs.
Key Duties & Responsibilities
Required Education Level
Master's degree or relevant comparable background & certifications.
Required Experience
10+ years of experience and 5+ years in a management/supervisory role, or the equivalent combination of education and experience in a regulated pharmaceutical environment
Preferred Masters Degree in pharmaceutical/health sciences.
Required Knowledge/Skills
* In-depth EU ATMPs health regulatory agency knowledge, human tissue establishment licensing and experience across GXP life cycle in Cell & Gene therapy and/or Biologics.
* Broad technical knowledge Tissue licensing and Tissue regulations in the EU and US..
* Current knowledge of industry trends and best practices in Cell/Gene therapies. Medical device knowledge a plus.
* Proven expertise / experience with strategies for gene- and cell therapy products, preparation and inspections.
* Demonstrated strategic planning and execution skills required for operational effectiveness and compliance.
* Operational Excellence experience with proven ability to lead improvement projects-Experience with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma.
* Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence.
* Ability to apply risk management principles to decision making and operational priorities.
* Critical Thinking and Problem Solving skills
Professional membership or equivalent in relevant societies, network of knowledge in cell and gene therapy industry.
Other Requirements
~15% Travel may be required.
Hybrid-Eligible Roles
In this Hybrid-Eligible role, you can choose to be designated as:
Hybrid: work remotely up to two days per week; or select On-Site: work five days per week on-site with ad hoc flexibility.
#LI-Hybrid #LI-ND2
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 ApplicationAssistance@vrtx.com.