Hybrid Associate Director, Clinical and Safety Quality Compliance

Posted last month

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About the role

  • Ensure compliance to Regulatory Intelligence Procedures
  • Execute the regulatory intelligence process in partnership with compliance teams
  • Implement change control for new and revised regulations
  • Oversee reviews and closure of routine and complex change controls
  • Provide data insights to emerging regulations and compliance metrics
  • Participate in enterprise-wide projects and initiatives
  • Support implementation of new and revised processes across CPMQ
  • Contribute to the Clinical and Safety Quality Compliance strategy as part of the Leadership Team

Requirements

  • BSc in a scientific or allied health/medical field (or equivalent degree)
  • Minimum of 7 years of increasing responsibility and relevant experience in the global pharmaceutical industry
  • At least 3 years of experience in GCP Quality/Compliance
  • Advanced knowledge of pharmaceutical development, medical affairs and GCP/GVP regulations (FDA, EU, MHRA, PMDA, ICH)
  • Successful development and implementation of a clinical or pharmacovigilance audit program
  • Experience hosting/leading regulatory inspections and remediation activities on a global level
  • Skilled in managing global, cross-functional projects
  • Successful management of business transformation/change management initiatives
  • Excellent communication skills and active listening skills
  • Outstanding problem-solving abilities
  • Fluency in written and spoken English, additional language skills a plus

Benefits

  • Medical, dental, vision insurance
  • 401(k) plan with company match
  • Short-term and long-term disability coverage
  • Basic life insurance
  • Tuition reimbursement program
  • Paid volunteer time off
  • Company holidays
  • Well-being benefits
  • Up to 80 hours of sick time per calendar year
  • Up to 120 hours of paid vacation for new hires

Job title

Associate Director, Clinical and Safety Quality Compliance

Job type

Experience level

Lead

Salary

$153,600 - $241,340 per year

Degree requirement

Bachelor's Degree

Location requirements

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