Назад
Company hidden
8 часов назад

Director, GPV Compliance & Business Management (QA)

186 489 - 278 875$
Формат работы
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
Director, GPV Compliance & Business Management (QA) (Pharmacovigilance Quality and Compliance): Leading global pharmacovigilance compliance systems, audit and inspection readiness, CAPA and deviation management, and vendor oversight with an accent on GxP quality systems, regulatory alignment, and cross-functional governance. Focus on designing inspection-readiness strategies, solving systemic compliance issues through root-cause analysis and remediation, and driving sustainable quality improvements across global PV operations.

Location: Princeton, New Jersey, United States

Salary: $186,489–$278,875 annually, plus incentive opportunity.

Company

hirify.global Pharmaceutical Companies supports pharmaceutical development and commercial operations, including global pharmacovigilance and quality activities.

What you will do

  • Lead the strategic direction and governance of global pharmacovigilance compliance systems in alignment with regulatory standards.
  • Direct global PV audit and inspection readiness, including planning, coordination, regulatory liaison, and post-inspection remediation.
  • Oversee CAPA, deviation, temporary change control, and standalone CAPA processes, ensuring effective investigations and timely closure.
  • Guide root-cause analysis, impact assessment, risk mitigation, and sustainable corrective actions for PV compliance issues.
  • Manage vendor performance and oversee alliance company and service-provider PV audit activities.
  • Collaborate with Global Quality, Regulatory Affairs, Clinical Management, affiliates, regional PV offices, and external pharmaceutical organizations.

Requirements

  • Bachelor's degree.
  • At least 6 years of pharmacovigilance compliance or pharmaceutical quality management experience, or relevant leadership experience.
  • Experience working in a global setting and managing vendor relationships and oversight.
  • Knowledge of ICH, U.S. and EU pharmacovigilance regulations, GVP, GCP, and inspections conducted by agencies such as the FDA and MHRA.
  • Experience with pharmaceutical quality compliance management systems and PV audits.
  • Strong project management, communication, presentation, strategic thinking, and influencing skills, with proficiency in Microsoft Office.

Culture & Benefits

  • Global, cross-functional work across affiliates, partner organizations, and regional PV offices.
  • Responsibility for leading internal colleagues and managing an external vendor team.
  • Medical, dental, vision, prescription drug, life, and disability insurance.
  • Tuition reimbursement, student loan assistance, and a company 401(k) match.
  • Flexible time off, paid holidays, and paid leave programs.
  • Travel may be required as applicable.

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 →