Regulatory Compliance Expert

vor 1 Monat

Zürich, Zürich, Schweiz Takeda Vollzeit

  • About This Role
  • This position is responsible for ensuring that clinical trials are conducted in compliance with regulatory requirements and company policies. The Associate Director, Clinical Quality Compliance will provide quality oversight to the clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management, and knowledge management.
  • Key Responsibilities
  • Partner with cross-functional teams to identify quality and compliance risks, conduct investigations, and develop corrective and preventive actions (CAPAs) to mitigate these risks.
  • Lead the clinical trial delivery system inspection readiness program, including the development of a strategy to ensure inspection readiness. Engage with relevant stakeholders and partners to drive accountability and transparency.
  • Requirements
  • Bachelor's degree in a scientific or allied health/medical field (or equivalent degree). Minimum of 10 years of increasing responsibility and relevant experience in the global pharmaceutical industry in functions such as Clinical Operations, Data Management and Statistics, with at least 5 years of experience in GCP Quality/Compliance.
  • Experience with pharmaceutical development, medical affairs, and GCP/GVP regulations, including FDA, EU, MHRA, PMDA, and ICH.
  • Experience must include successful implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections, and remediation activities on a global level.
  • About Takeda
  • Takeda is a patient-focused company that is transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. We are committed to equitable pay for all employees and strive to be more transparent with our pay practices.
  • U.S. Compensation and Benefits
  • U.S. Base Salary Range: $149,100.00 - $234,300.00. U.S.-based employees may be eligible for short-term and/or long-term incentives, medical, dental, vision insurance, a 401(k) plan, company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits.
  • Locations
  • Boston, MA. Zurich, Switzerland

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