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9 дней назад

Director, Facilities & Equipment Quality Strategy, and Technical Oversight Support

191 250 - 247 500$
Формат работы
onsite
Тип работы
fulltime
Грейд
director
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
Director, Facilities & Equipment Quality Strategy, and Technical Oversight Support (GMP facilities, utilities, and equipment): Leading global Quality strategy and technical oversight for regulated infrastructure and assets across a biopharmaceutical network with an accent on lifecycle compliance, risk-based governance, and reliability. Focus on harmonizing quality programs, overseeing commissioning and validation, guiding investigations and CAPA, and supporting regulatory submissions and inspections.

Location: United States - California - Santa Monica

Salary: $191,250–$247,500 per year, with potential annual bonus, stock-based long-term incentives, paid time off, and benefits.

Company

hirify.global is a biopharmaceutical company developing personalized CAR T-cell and T-cell receptor therapies for cancer treatment.

What you will do

  • Define and maintain enterprise quality policies, standards, strategies, and lifecycle controls for GMP facilities, utilities, and equipment.
  • Provide independent Quality oversight and approval for infrastructure, assets, new process design, facility start-up, commissioning, qualification, and validation.
  • Lead network-wide harmonization, continuous improvement, governance, and reliability initiatives.
  • Guide risk-based decisions, significant investigations, corrective and preventive actions, and lessons-learned programs.
  • Oversee Quality input for regulatory submissions, inspections, observations, and commitments through closure.
  • Partner with Facilities, Engineering, Manufacturing, Quality, suppliers, and senior stakeholders while building organizational capability through mentoring and knowledge programs.

Requirements

  • PhD with 8+ years, Master’s degree with 10+ years, Bachelor’s degree with 12+ years, Associate’s degree with 14+ years, or High School diploma with 16+ years of relevant experience.
  • Relevant experience in facilities management, engineering, quality assurance, or a related field within a regulated environment.
  • In-depth knowledge of U.S. and international GMP requirements, standards, and best practices for facilities, utilities, and equipment.
  • Ability to develop risk-based solutions, analyze reliability data, and communicate complex technical and Quality matters to technical, business, and executive audiences.
  • Experience with quality oversight for commissioning, qualification, and validation of facilities, utilities, and equipment.
  • Work location: United States, California, Santa Monica.

Nice to have

  • Experience leading global, cross-functional facilities, utilities, and equipment quality programs.
  • Experience with reliability engineering and risk-based principles for pharmaceutical or similar manufacturing assets.
  • Experience with cell and gene therapy manufacturing and related infrastructure requirements.
  • Relevant professional certification such as CQE or CQA.

Culture & Benefits

  • Mission focused on developing innovative cancer immunotherapies and improving long-term patient outcomes.
  • Inclusive environment focused on employee development, empowerment, accountability, and continuous improvement.
  • Medical, dental, vision, and life insurance plans.
  • Paid time off and potential discretionary annual bonus and stock-based long-term incentives.

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