Data Systems QA and Compliance Expert

6 days ago


Lexington, Massachusetts, United States Takeda Development Center Americas, Inc Full time
Job Title: Data Systems QA and Compliance Leader

Takeda Development Center Americas, Inc. is seeking a highly skilled professional 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 test software systems.
  • Conduct risk assessments and develop mitigation plans to address potential compliance risks.
  • Provide training and support to employees on computer system validation best practices.
  • Stay up-to-date with changing regulatory requirements and industry standards.

Requirements:

  • Strong understanding of computer system validation principles and regulatory requirements.
  • Excellent communication and collaboration skills.
  • Ability to work in a fast-paced environment and prioritize multiple tasks.
  • Strong analytical and problem-solving skills.
  • Experience with software development and testing methodologies.

What We Offer:

  • Opportunity to work with a global R&D organization.
  • Collaborative and dynamic work environment.
  • Competitive salary and benefits package.
  • Professional development opportunities.

Travel Requirements:

Up to 20% domestic and international travel required for this role.



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