5 часов назад
Clinical FSP Quality Manager
151 200 - 659 300PLN
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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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