Sr. Manager, Quality Validation

Indivior

Richmond, VA, United States
Not specified; eligible for compyny bonus based on...
Hybrid
10 years pharmaceutical manufacturing experience
8 years validation leadership in regulated industry
Root cause analysis and capa implementation skills
Indivior is seeking a Sr. Manager, Quality Validation to oversee validation strategies for their pharmaceutical manufacturing processes, ensuring compliance with regulatory standards. The ideal candidate will have extensive experience in pharmaceutical quality and validation, particularly in sterile manufacturing and regulatory compliance

Job Summary

  • The Sr. Manager, Quality Validation is responsible for developing the validation strategy for Indivior and third-party manufacturing to ensure patient safety and regulatory compliance.
  • This role serves as the validation subject matter expert, leading activities for process validation, sterile manufacturing, utilities, and computer systems across global operations.
  • Indivior offers competitive benefits including a bonus program, long-term incentive plan grants, comprehensive medical coverage, and tuition reimbursement.

Matching Summary

Match Score: 85

Indivior is seeking a Sr. Manager, Quality Validation to oversee validation strategies for their pharmaceutical manufacturing processes, ensuring compliance with regulatory standards. The ideal candidate will have extensive experience in pharmaceutical quality and validation, particularly in sterile manufacturing and regulatory compliance.

Salary

Not specified; Eligible for company bonus based on performance; Yearly grant via Long-Term Incentive Plan

Skills & Requirements

Must-have

  • 10 years pharmaceutical manufacturing experience
  • 8 years validation leadership in regulated industry
  • Root cause analysis and CAPA implementation skills
  • Sterile and microbiological manufacturing experience
  • Knowledge of Annex 1, FDA, EMA, and ICH requirements
  • Experience with third-party CMO/CPO validation oversight

Nice-to-have

  • Master's degree in Engineering or Life Sciences
  • Strong analytical and strategic thinking capabilities
  • Entrepreneurial mindset with bias for action
  • Experience with new product technical transfer
  • Ability to drive continuous improvement initiatives

Key Requirements

  • Bachelor's degree required; Master's preferred
  • Minimum 10 years pharmaceutical quality/manufacturing experience
  • At least 8 years in validation execution and leadership
  • Direct experience with root cause analysis (RCA)
  • Strong understanding of small molecule products

Work Rights

Not specified

Tailored Resume

Cover Letter