Head of Compliance Operations

4 days ago


Boston, Massachusetts, United States Takeda Pharmaceutical Company Ltd Full time
Job Description

Overview

Takeda Pharmaceutical Company Ltd is seeking a highly skilled and experienced professional to fill the role of Head of Compliance Operations. This position will be responsible for providing strategic direction and leadership in establishing and maintaining a robust compliance program across the organization.

Key Responsibilities

  • Develop and implement a comprehensive compliance strategy that aligns with global quality and regulatory requirements.
  • Provide direction and oversight to ensure compliance with all relevant laws, regulations, and industry standards.
  • Collaborate with cross-functional teams to identify and mitigate compliance risks.
  • Develop and maintain internal functional processes and systems to enable optimization in the execution and oversight of clinical and safety quality compliance activities.
  • Lead the development, implementation, and refinement of functional quality compliance processes and systems, ensuring alignment with global quality and R&D quality processes.
  • Provide strategic direction on escalation pathways for significant non-compliance process and system issues and/or risks.
  • Ensure the proactive monitoring of the health of the QMS and the sharing of compliance metrics for CPMQ activities.

Requirements

  • Bachelor's degree in a scientific or allied health/medical field (or equivalent degree).
  • Minimum of 8 years of increasing responsibility and relevant experience in the global pharmaceutical industry, with at least 5 years of quality/compliance experience.
  • Advanced knowledge of clinical research and pharmacovigilance throughout R&D and commercialization, and relevant regulations including GCP/GVP.
  • Experience in development and implementation of audit programs, hosting/leading regulatory inspections, investigation and remediation activities on a global level, and successful management of business transformation/change management initiatives.
  • Excellent communication skills to convey messages and exceptional active listening skills to understand the needs and concerns of others.
  • Outstanding ability to apply critical thinking and problem-solving abilities to address challenges and advocate for solutions.
  • Fluency in written and spoken English, additional language skills a plus.

What We Offer

Takeda offers a competitive compensation package, including a base salary range of $169,200.00 - $266,200.00, as well as opportunities for professional growth and development.

Equal Employment Opportunity

Takeda is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating a diverse and inclusive workplace that reflects the communities we serve.



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