13 дней назад
Director, GTS Quality Systems (Veeva)
172 500 - 232 500$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Director, GTS Quality Systems (Veeva): Leading the operation, deployment, and lifecycle support of enterprise QMS and Quality Assurance systems in a regulated pharmaceutical environment with an accent on Veeva Quality applications, GxP compliance, and validated system operations. Focus on translating Quality requirements into technology roadmaps, coordinating deployments and validation evidence, managing vendors and budgets, and supervising Quality technology delivery.
Location: Hopewell, United States; periodic domestic and international travel of less than 20%
Salary: $172,500–$232,500 annually
Company
is a biopharmaceutical company focused on developing and delivering medicines to patients, including treatments for cancer.
What you will do
- Lead technology delivery, deployment, operations, and lifecycle support for enterprise QMS, Veeva Quality, and other regulated Quality Assurance systems.
- Translate Quality business requirements and GxP compliance expectations into technology plans, system enhancements, support models, and delivery commitments.
- Manage application operations, incident and problem management, release coordination, configuration oversight, service metrics, user support, and lifecycle planning.
- Lead Veeva Quality deployment activities, including solution design input, configuration review, integration and data considerations, testing, defect resolution, and post-go-live stabilization.
- Manage project scope, schedules, resources, budgets, risks, vendors, stakeholders, and operational readiness across Quality technology initiatives.
- Maintain the Quality Systems roadmap and partner with Quality, GTS, architecture, cybersecurity, data, procurement, finance, and external vendors.
Requirements
- Bachelor’s degree in Engineering, Computer Science, or a related technology field with at least 7 years of relevant experience, or a master’s degree with at least 5 years of relevant experience.
- Hands-on experience implementing, configuring, supporting, and operating Veeva Quality applications and enterprise QMS or Quality Assurance systems.
- Experience in pharmaceutical, biotechnology, life sciences, or another regulated GxP environment.
- Knowledge of document control, training, deviations, CAPA, change control, complaints, audits, quality risk management, supplier quality, and inspection readiness.
- Working knowledge of 21 CFR Part 11, data integrity, GxP computer system validation, Computer Software Assurance, change control, access management, and validated system operations.
- Experience with GTS or IT delivery, service management, vendor management, roadmap and demand management, budget management, and cross-functional technology delivery; direct supervision of approximately three employees is expected.
Nice to have
- Experience with ValGenesis, Inspection Management, AI tools used in pharma, laboratory systems, manufacturing systems, training systems, or other regulated Quality platforms.
Culture & Benefits
- Values include Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit.
- Benefits include medical, dental, and vision coverage; 401(k); FSA/HSA; life insurance; paid time off; and wellness programs.
- Eligibility for annual bonus participation, discretionary equity awards, and an Employee Stock Purchase Plan.
- Work includes collaboration with global Quality, GTS, site teams, vendors, and managed service partners.
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