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14 дней назад

Compliance Manager, Clinical Supply Chain (Biopharma)

124 000 - 161 000$
Формат работы
hybrid
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Compliance Manager, Clinical Supply Chain (Biopharma): Managing compliance activities across clinical supply chains for Phase I–IV studies with an accent on audit readiness, clinical trial material distribution, vendor coordination, and cGxP compliance. Focus on designing and testing IRT systems, managing supply-chain risks, maintaining TMF documentation, and coordinating packaging, labeling, and distribution processes.

Location: Hybrid role based out of the Bridgewater, New Jersey office, with remote work available most of the time and in-person collaboration as needed. Occasional global travel of approximately 5%–15% is required.

Salary: $124,000–$161,000 annual

Company

hirify.global is a global biopharmaceutical company focused on transforming the lives of patients with serious and rare diseases.

What you will do

  • Manage compliance activities and audit readiness for clinical supply chain studies and projects from Phase I through Phase IV.
  • Support TMF index development, regulatory documentation, and regular TMF updates.
  • Support IRT system design and user acceptance testing, and manage clinical supply chain change controls.
  • Coordinate external packaging, labeling, distribution, and clinical supply vendors.
  • Represent Supply Chain & Logistics in cross-functional study meetings and communicate project information to stakeholders.
  • Identify and mitigate supply chain risks, manage supplier performance metrics, and develop compliant SOPs, work practices, and procedures.

Requirements

  • Bachelor’s degree and 5+ years of experience in drug development, clinical supply chain management, or clinical manufacturing operations.
  • Working knowledge of GMP, GCP, and ICH guidelines.
  • Experience working with or managing external vendors.
  • Ability to identify risks, manage processes, and develop operationally achievable solutions.
  • Proficiency with Microsoft Excel, PowerPoint, and Word, with strong collaboration and multitasking skills.
  • Ability to act with a sense of urgency and manage multiple projects simultaneously.

Nice to have

  • Experience with MS Project and demand and supply-related software systems.

Culture & Benefits

  • Purpose-driven environment focused on patients with serious and rare diseases.
  • Medical, dental, vision, and mental health coverage, plus annual wellbeing reimbursement and an Employee Assistance Program.
  • Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
  • 401(k) plan with company match, annual equity awards, ESPP participation, and company-paid life and disability insurance.
  • Learning programs, mentorship, employee resource groups, service initiatives, and recognition programs.

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