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5 часов назад

Clinical FSP Quality Manager

151 200 - 659 300PLN
Формат работы
hybrid
Тип работы
fulltime
Грейд
senior
Английский
c1
Страна
Poland
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Мэтч & Сопровод

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Описание вакансии

Текст:
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TL;DR
Clinical FSP Quality Manager (Clinical Research/Quality Management): Implementing quality management plans, risk management programs, and compliance processes for clinical study delivery with an accent on ICH-GCP, regulatory requirements, and corrective/preventive actions. Focus on identifying quality risks, managing non-compliance, supporting audits and inspections, and coordinating quality improvements with clinical and Quality Assurance teams.

Location: Warsaw, Poland; attendance at the sponsor office three times per week is required

Salary: PLN 151,200–659,300 annualized base pay

Company

IQVIA provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

  • Implement global quality management plans within assigned delivery units, sponsors, business lines, and tasks.
  • Plan and execute quality activities, identify and assess risks through data review and quality control, and support risk mitigation.
  • Develop and monitor delivery unit or sponsor-specific quality management plans and risk management programs.
  • Advise clinical teams and stakeholders on Good Clinical Practice compliance, quality issues, and corrective/preventive actions.
  • Coordinate with Quality Assurance during suspected misconduct cases, audits, and regulatory inspections.
  • Prepare periodic reports on quality matters, risk assessments, and quality improvement initiatives.

Requirements

  • Bachelor's degree or equivalent qualification.
  • At least 5 years of experience in the pharmaceutical industry, preferably in Development Operations or Quality Assurance.
  • Good knowledge of ICH-GCP, relevant local regulations, the drug development process, and GXP activities.
  • Understanding of clinical study delivery, including study management, site management, and monitoring.
  • Excellent organizational, communication, presentation, prioritization, and multitasking skills, with strong attention to detail and high ethical standards.
  • Excellent spoken and written English; ability to work with IT systems and travel nationally and internationally as required.

Culture & Benefits

  • 12-month fixed-term contract with a possibility of extension.
  • Collaboration with global or regional Quality Management teams, clinical functions, Quality Assurance, and other stakeholders.
  • Health and welfare benefits may be provided depending on the position and compensation package.
  • Potential additional incentive plans, bonuses, or other forms of compensation may be offered.

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