Job Description
General Summary:
The Validation Senior Manager position will be part of the Vertex Cell and Genetic Therapy Manufacturing Operations and Technical Operations group. The role will oversee Validation personnel and support managing day-to-day Validation operations at VCGT facilities for the T1D program at the greater Boston location. This role will be involved in various aspects of validation including equipment, computerized systems and software, cleaning, sterilization, and shipping qualification. The incumbent will be responsible for managing and supporting personnel for validation of existing equipment and new capital projects (as required), enhancements and capabilities from conceptual to detailed design, installation, testing, commissioning, qualification, validation, periodic assessments, and revalidation.
Key Duties and Responsibilities:
- Manage in-house staff and seasonal consultants supporting key CQV deliverables.
- Manage periodic assessment and revalidation activities as part of Validation Maintenance activities.
- Participate in design reviews for various capital projects and equipment with cost, efficiency, and compliance always in mind, if required.
- Lead IQ, OQ, PQ efforts for utilities, facility, and analytical equipment.
- Coach and mentor reports to assure that the team is attuned with changes in regulatory and industry standards.
- Perform validation assessments for various projects (change controls, capital projects, etc.).
- Provide SME support for regulatory inspections from the Validation standpoint whenever required.
- Assist in the development of Validation KPIs and ensure they are appropriately monitored, tracked, and reported.
- Work collaboratively with Manufacturing, Process/Analytical Development, R&D groups, EH&S, Capital Project Management, GIS, QA, and others to support the consistent achievement of the company's strategic objectives and meet aggressive timelines.
- Manage the Site Validation Master Plan and Requalification Master Plans.
- Cultivate change and innovation by seeking opportunities to strengthen and improve the existing Validation program.
- Serve as an advisor to reports and involve directly to resolve issues and/or meet timelines.
- Support activities related to the APS program.
Knowledge and Skills:
- Expert knowledge of validation and system implementations in a GMP manufacturing environment.
- Direct experience with process equipment and systems qualification, sterilization qualification, critical utilities validation, cleaning validation, and temperature mapping is a must.
- Strong knowledge across technical areas.
- Has emerging competence in a supervisory role.
- Demonstrates strong aptitude in helping to lead a group or team endeavor and building team unity.
- Communicates clearly and concisely (written and verbal) across levels of the company.
- Working knowledge of current applicable regulations, standards, and guidance like 21CFR 210, 211, Part 11, ISO 14644, EU Annex 1, ATMP, EU Annex 15, USP <1058>, GAMP, etc.
- Must be able to establish strong working relationships with stakeholders (Quality, DPF, Tech Ops, Engineering, GXP Operations, and GIS) to ensure high-quality deliverables meeting cGMP and Vertex validation requirements.
- Ability to perform complex assessments for automated processing systems against current industry compliance requirements.
- Demonstrable team leadership, problem-solving, creative and critical thinking, and project planning skills.
- Ability to navigate and be successful in a fast-paced, highly matrixed work environment.
- Displays high competence in the utilization of core quality systems such as change control, deviations, investigations, CAPA management, and document control.
Education and Experience:
- Bachelor's or Master's degree in Biotechnology, Chemical, Industrial, or Biomedical Engineering, or a related discipline.
- Typically requires 6 years of experience in a related field and 1 year of supervisory/management experience or the equivalent combination of education and experience.