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Clinical Quality Assurance Manager - Investigational Medicinal Product (IMP)

Posted 2024-11-20

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💎 Seniority level: Manager, More than ten (10) years

💸 Salary: 105000 - 125000 USD per year

🔍 Industry: Biopharmaceutical

🗣️ Languages: English

⏳ Experience: More than ten (10) years

Requirements:
  • Bachelor’s degree or equivalent education in life sciences or healthcare.
  • More than ten (10) years of experience in pharmaceutical or biotech industry.
  • Extensive experience in QA operations including GMP and GDP.
  • Strong understanding of US and European regulations.
  • Knowledge of risk assessment and risk management tools.
  • Fluent in spoken and written English.
  • Ability to travel approximately 25% of the time.
Responsibilities:
  • Coordinate a team for IMP quality compliance.
  • Set goals/objectives and conduct performance reviews.
  • Manage KPIs for IMP supplier quality assurance activities.
  • Serve as central contact for internal and external QA inquiries, deviations, and audit observations.
  • Ensure compliance with change requests and complaints as per Quality Agreement.
  • Collaborate with internal teams on quality assessments and issues.
  • Attend and contribute to IMP supplier QA and business review meetings.
  • Review batch records for clinical trials and support external audits.
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