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7 дней назад

R&D Supplier Quality Sr Manager

132 037 - 178 638$
Формат работы
remote (только USA)
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
R&D Supplier Quality Sr Manager (GMP/GDP): Providing risk-based quality governance and oversight for R&D suppliers and service providers supporting clinical development with an accent on supplier qualification, regulatory compliance, and cross-functional decision-making. Focus on triaging complex supplier-quality issues, maintaining Quality Agreements and KPIs, and escalating risks affecting patient safety, product quality, and clinical trial timelines.

Location: United States - Remote; willingness to travel up to 15% required.

Annual salary: USD 132,037.30–178,638.70.

Company

hirify.global is a biotechnology company developing and manufacturing medicines for serious illnesses, including heart disease, rare diseases, inflammatory conditions, and cancer.

What you will do

  • Provide risk-based quality governance and oversight for R&D suppliers and clinical service providers across GCP, GLP, GPvP, GMP, and GDP requirements.
  • Facilitate a cross-functional R&D and Operations forum for clinical quality issues involving GMP/GDP requirements and unclear ownership.
  • Coordinate intake and risk-based triage of complex supplier and quality issues, identifying applicable requirements, risks, subject matter experts, and accountable functions.
  • Develop and maintain supplier qualification strategies, Quality Agreements, supplier requirements, quality records, KPIs, and metrics.
  • Drive escalation, documentation, and continuous improvement for risks affecting patient safety, product quality, regulatory compliance, or clinical trial timelines.

Requirements

  • Doctorate degree and 2 years of relevant experience, or a master's degree and 4 years, bachelor's degree and 6 years, associate's degree and 10 years, or high school diploma/GED and 12 years of Quality Management or relevant experience.
  • Experience in supplier quality management or oversight, preferably in clinical supply chain quality or GMP/GDP-regulated services.
  • Working knowledge of GCP, GLP, GPvP, GMP, and GDP regulations and practices.
  • Strong project management, quality risk management, leadership, negotiation, analytical, communication, and influencing skills.
  • Experience working in complex, global, matrixed organizations across multiple functions and time zones.
  • Must be based in the United States and willing to travel up to 15%.

Nice to have

  • Experience with contract negotiations and supplier relationship building.
  • Experience with transactional lean, value stream mapping, and process design improvement.
  • Experience using tools and systems that support supplier quality management processes.

Culture & Benefits

  • Collaborative, innovative, science-based work environment.
  • Health, dental, vision, life, disability, and flexible spending benefits.
  • Retirement and savings plan with company contributions.
  • Discretionary annual bonus program and stock-based long-term incentives.
  • Paid time off and career development opportunities.

Hiring process

  • Applications are accepted until a sufficient number of candidates are received or a candidate is selected.
  • Visa sponsorship is not guaranteed.

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