Clinical Compliance Director

7 days ago


San Diego, California, United States Hologic Full time
Job Summary

Oversee a comprehensive compliance program for Hologic Diagnostic Solutions Clinical Affairs, ensuring adherence to regulatory requirements and industry standards. Develop and implement strategic frameworks for clinical compliance, fostering a culture of integrity and driving risk management through proactive compliance programs.

Key Responsibilities
  • Set the strategic direction for clinical compliance, engaging stakeholders and working cross-functionally to drive business operations.
  • Lead the development, approval, and periodic review of controlled documents related to clinical study processes and systems.
  • Maintain expert knowledge of current and proposed clinical research-related laws, regulations, and guidelines.
  • Collect and disseminate clinical regulatory intelligence to the organization, participating in industry and regulatory working groups.
  • Align with divisional and corporate leadership to ensure synergy and consistency across programs and product lines.
  • Ensure audits of clinical trial master files, clinical trial sites, clinical suppliers, and clinical department systems are conducted and reported on a periodic or as-needed basis.
  • Assume responsibility for the core training and career development of direct reports, ensuring they receive appropriate management and technical support and training.
Qualifications
  • Minimum 8 years of experience in Audit, Compliance, Risk, Assurance, and Governance, ideally with international and team leadership experience in clinical research.
  • Strong knowledge of relevant international clinical compliance policies and regulations, and solid understanding of the diagnostics and healthcare industry.
  • Intercultural understanding and experience in change and project management.
Why Join Hologic?

We are committed to making Hologic the company where top talent comes to grow. We provide comprehensive training when you join, as well as continued development and training throughout your career.



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