Senior Director, Quality Mfg & Quality eSystems/Digital Technology (Cell and Gene)

Job Description

General Summary:

A Quality Manufacturing Technology Senior Director / Director is a senior leadership role responsible for overseeing the quality and manufacturing technology functions across an organization. This role is accountable for ensuring Operational Systems related improvements and projects are planned, prioritized, and executed in a systematic manner. The role is accountable for leading/supporting continuous improvements of quality operations processes, development of digital roadmaps including Quality user requirements, details of Quality process flows and assuring realization of such requirements into systems and procedures.
The role provides Quality oversight to assure that the Quality requirements are appropriately built in and executed within the key Vertex initiatives such as commercial launches, technology projects and efficiency driving measures.
The role will be highly cross-functional and will require meticulous planning, resources allocation and effective partnering with quality and other stakeholders - MSAT, DTE, QC - to participate in Cell and Gene therapies program oversight and associated governance.

Key Duties & Responsibilities

*Partner with cross-functional teams to support the development and establish quality requirements that are in alignment with the CGT business objectives and manufacturing technology roadmap.
*Oversee the quality responsibilities for the development of manufacturing technology solutions to drive innovation, efficiency, and productivity
*Lead the development and implementation of continuous improvement quality operations activities and processes.
*Ensure Quality Operations processes are digitized in compliance with regulations. Proactively identify gaps and mitigate risks.
*Participate in development the strategy for project and represent as the quality expert in technology / digitization governance forums to ensure Quality requirements are appropriately included and prioritized for implementation.
*Leverage technical expertise and experiences across QA to resolve critical challenges; ensure effective communication and escalation where needed.
*Represent Quality in Cell & Gene Programs and serve as a trusted advisor and partner to establish the CMC quality strategy and roadmap for innovative therapeutic programs.
*Provides quality leadership and partner with operational stakeholders to ensure effective resolution and mitigation of risks.
*Represent C&G Quality to lead/participate in complex projects and partner with key stakeholders for alignment in strategic and operational planning and delivery of business & financial priorities and goals.
*Create and foster a culture of collaboration, development, and engagement for advancing quality outcomes and operational excellence.
*Lead and mentor other team members, support development of organizational capabilities and talent building.

Knowledge and Skills:

Broad experienced in quality assurance operations role for a allogeneic/autologous cell manufacturing process and/or biologics process from development to Commercial life cycle

* In-depth global health regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics.
* 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.
* Effective business analytical skills to allow for critical analysis of the processes and practices.
* Ability to chair governance meetings, and establish dashboards, reporting. Solid project management skills, ability to work on advanced reporting industry standard solutions such as Smartsheet, PowerBI.
* Foster a culture of quality, innovation, and continuous improvement across the organization
* Influencing/building/promoting a culture of Quality Excellence
* Strong leadership, ability to work in a matrix environment and an innate ability to collaborate and build relationships

Education and Experience:

* Bachelor's degree in an engineering/Lifesciences field.
* Preferred: Additional Master's degree in business analytics/management/industrial engineering/ Operational excellence certified.

12+ years of experience and 5+ years in a management/supervisory role, or the equivalent combination of education and experience in a regulated pharmaceutical environment

Other Requirements:

15% travel
Hybrid role in Boston, MA

Flex Designation:

Flex Eligibility Status:

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