Sr. Manager, Quality Validation

Indivior

Richmond, VA, United States
Validation master plan
Process validation
Computer systems validation
The Sr. Manager, Quality Validation is responsible for developing validation strategy for Indivior and third-party manufacturing, packaging and testing, ensuring compliance with regulatory requirements and industry standards

Job Summary

  • The Sr. Manager, Quality Validation is responsible for developing validation strategy for Indivior and third-party manufacturing, packaging and testing, ensuring compliance with regulatory requirements and industry standards.
  • Responsibilities include leading validation activities for processes, sterile manufacturing, oral solid dose, utilities, and computer systems, as well as overseeing activities at third-party CMOs/CPOs.
  • Indivior offers a comprehensive benefits package including 3 weeks vacation plus holidays, 401(k) with profit sharing, stock purchase plan, and robust health and wellness benefits.

Matching Summary

The Sr. Manager, Quality Validation is responsible for developing validation strategy for Indivior and third-party manufacturing, packaging and testing, ensuring compliance with regulatory requirements and industry standards.

Skills & Requirements

Must-have

  • Validation Master Plan
  • Process Validation
  • Computer Systems Validation
  • cGMP and global regulations
  • Risk-based validation approach
  • Root cause analysis skills

Nice-to-have

  • Entrepreneurial and self-motivated
  • Bias for action
  • Strategic thinking capabilities
  • Continuous Improvement activities

Key Requirements

  • Bachelor’s degree in Engineering, Life Sciences or related field
  • Minimum ten (10) years pharmaceutical manufacturing or quality experience
  • At least eight (8) years in validation
  • Strong sterile and microbiological experience
  • Strong understanding of small molecule products
  • Broad knowledge of current GMPs and international regulatory requirements

Work Rights

Not specified

Tailored Resume

Cover Letter