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Data Systems Quality Assurance and Compliance Director

2 months ago


Lexington, Massachusetts, United States Takeda Development Center Americas, Inc Full time

Job Summary:

Takeda Development Center Americas, Inc. is seeking a highly skilled Data Systems Quality Assurance and Compliance Director to serve as a subject matter expert in computer system validation requirements for systems used by Takeda's global R&D organization.

Key Responsibilities:

  • Develop and implement computer system validation strategies to ensure compliance with regulatory requirements.
  • Collaborate with cross-functional teams to design, develop, and implement data systems that meet quality and compliance standards.
  • Conduct risk assessments and implement controls to mitigate risks associated with data systems.
  • Provide training and guidance to employees on computer system validation and compliance procedures.
  • Develop and maintain documentation to support computer system validation and compliance activities.

Requirements:

  • Minimum 5 years of experience in computer system validation and compliance.
  • Strong knowledge of regulatory requirements and industry standards.
  • Excellent communication and interpersonal skills.
  • Ability to work in a fast-paced environment and prioritize multiple tasks.

What We Offer:

  • Competitive salary range: $177,500 - $186,000 per year.
  • Opportunities for professional growth and development.
  • Collaborative and dynamic work environment.