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5 дней назад

Senior Manager, RDQA (Americas)

124 500 - 236 500$
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
Senior Manager, RDQA (Americas) (Clinical Quality Assurance): Driving proactive quality management and regulatory readiness for clinical research activities across designated Americas affiliates with an accent on quality systems, risk mitigation, audits, and health authority inspections. Focus on developing inspection strategies, identifying root causes and compliance risks, leading corrective action plans, and mentoring regional quality managers.

Location: Hybrid role based at an AbbVie location in the United States, including North Chicago, IL; Cambridge, MA; Worcester, MA; Irvine, CA; San Francisco, CA; or Florham Park, NJ. Travel within the assigned area may reach 35%.

Salary: $124,500–$236,500 USD per year, plus eligibility for long-term incentive programs.

Company

AbbVie develops innovative medicines and solutions across therapeutic areas including immunology, oncology, neuroscience, and aesthetics.

What you will do

  • Drive proactive quality management and quality strategy for clinical research activities across designated affiliates and countries.
  • Collaborate with RDQA, clinical development, and affiliate R&D leaders to advance the AbbVie Quality System and support first-pass regulatory approvals.
  • Develop risk identification, mitigation, quality measures, and continuous-improvement strategies for clinical trials.
  • Oversee quality and compliance in accordance with company policies, regional standards, regulations, and regulatory expectations.
  • Develop inspection strategies, support health authority inspections, and coordinate inspection responses.
  • Conduct or oversee audits, supplier visits, vendor qualifications, corrective action plans, and mentoring of AREA managers and associates.

Requirements

  • Bachelor’s degree required, preferably in biology, nursing, pharmacy, or another medical science, or equivalent technical experience.
  • 8+ years of biopharmaceutical or medical device industry experience in quality assurance, compliance, regulatory affairs, clinical research, or related development functions.
  • At least 3 years of leadership experience involving people, initiatives, or projects.
  • Thorough knowledge of quality systems, auditing standards, quality management, and local and global regulatory requirements.
  • Strong analytical, communication, negotiation, influencing, collaboration, and networking skills.
  • Ability to work in a hybrid arrangement at an AbbVie location in the United States and travel within the assigned area as needed.

Culture & Benefits

  • Collaborative work across global and local R&D and clinical research functions.
  • Paid time off, including vacation, holidays, and sick leave.
  • Medical, dental, and vision insurance for eligible employees.
  • 401(k) benefits for eligible employees.
  • Participation in long-term incentive programs.

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