Назад
Company hidden
5 дней назад

Associate Director, GMP Quality CGT Personalized Medicine

148 000 - 222 000$
Формат работы
hybrid/onsite
Тип работы
fulltime
Грейд
director
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
Для мэтча и отклика нужен Plus

Мэтч & Сопровод

Для мэтча с этой вакансией нужен Plus

Описание вакансии

Текст:
/
TL;DR
Associate Director, GMP Quality CGT Personalized Medicine (GMP Quality/Cell and Gene Therapy): Leading quality systems, risk management, data integrity, and continuous improvement for personalized medicine and advanced CGT programs with an accent on global GMP compliance, lifecycle management, and cross-functional governance. Focus on designing quality processes, resolving complex compliance issues, improving data integrity, and applying AI and digital reporting to strengthen decision-making and operational risk management.

Location: Boston, MA, United States; hybrid work with up to two remote days per week or on-site work five days per week

Salary: $148,000–$222,000 base salary per year, plus annual bonus and equity awards

Company

Vertex is a global biotechnology company focused on scientific innovation and therapies for patients.

What you will do

  • Lead quality systems, risk management, compliance governance, and quality culture initiatives across the Cell and Gene Therapy organization.
  • Partner with technical development, commercial, Quality, digital, Manufacturing Science and Technology, and disease area stakeholders to embed personalized medicine requirements into quality system lifecycle projects.
  • Lead VCGT change management operations across clinical, launch, and commercial product lifecycle stages.
  • Drive process improvement, governance, escalation, operational readiness, and remediation planning for quality systems.
  • Lead the VCGT Data Integrity program, including risk mitigation, reporting, investigations, and local site implementation.
  • Support digital reporting solutions and the use of artificial intelligence to improve quality risk decision-making and governance.

Requirements

  • Bachelor’s degree in a scientific discipline, operations research, operations management, business administration, or a related field.
  • 8+ years of experience or an equivalent combination of education and experience.
  • Experience across the product lifecycle from discovery through commercial development.
  • Deep expertise in global GMP regulations, guidance, Quality Management, and GxP industry standards.
  • Ability to lead complex projects and teams, influence cross-functional stakeholders, and work effectively in a matrix environment.
  • Strong technical writing, presentation, communication, facilitation, coaching, and project management skills.

Culture & Benefits

  • Hybrid or on-site work arrangement under the Flex @ Vertex program.
  • Medical, dental, and vision benefits with paid time off and summer and winter company shutdowns.
  • Educational assistance programs, including student loan repayment support.
  • Commuting subsidy, matching charitable donations, and 401(k) benefits.
  • Up to 5% travel.
  • Continuous learning focused on AI, technology, automation, and industry trends.

Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →