Sr. Manager, R&d Quality Compliance And Systems

Takeda

Lexington, MA, USA
Base: $137,000.00 - $215,270.00; bonus/equity: eli...
Gxp regulatory compliance expertise
Risk management strategy implementation
Audit and inspection readiness execution
This role provides cross-functional expertise to ensure the R&D Quality organization remains robust, aligned with, and compliant to applicable regulatory requirements

Job Summary

  • This role provides cross-functional expertise to ensure the R&D Quality organization remains robust, aligned with, and compliant to applicable regulatory requirements.
  • The successful candidate will be responsible for autonomously executing activities associated with the RDQ framework of audit and inspection management, risk management, and incident escalation.
  • U.S. based employees are eligible for short-term and long-term incentives along with comprehensive benefits including medical, dental, vision, and a 401(k) plan.

Matching Summary

This role provides cross-functional expertise to ensure the R&D Quality organization remains robust, aligned with, and compliant to applicable regulatory requirements.

Salary

Base: $137,000.00 - $215,270.00; Bonus/Equity: Eligible for short-term and/or long-term incentives; Benefits: Medical, dental, vision, 401(k), paid vacation, sick time

Skills & Requirements

Must-have

  • GxP regulatory compliance expertise
  • Risk management strategy implementation
  • Audit and inspection readiness execution
  • Gap assessment process application
  • Quality Management System stewardship

Nice-to-have

  • Six Sigma or Lean processing certification
  • Project management professional certification
  • Auditor certification preferred
  • Cross-functional collaboration skills
  • Continuous improvement initiative experience

Key Requirements

  • Bachelor's Degree in Chemistry, Biology, Engineering, or related field
  • Minimum 8 years professional experience in healthcare products
  • At least 4 years in GMP Quality or Compliance
  • Experience working within complex matrixed organizations

Work Rights

Not specified

Tailored Resume

Cover Letter