Hybrid Vice President – Sterility Assurance

Posted 3 days ago

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About the role

  • Own and deploy sterility assurance strategy, standards, and governance to ensure compliance to regulatory expectations
  • Lead cross-functional alignment and risk mitigation across Engineering, QA, and MSAT
  • Ensure contamination control strategy is standardized and embedded in QMS
  • Oversight of facility design and equipment reliability aligned with sterility assurance requirements
  • Lead cleaning validation, process control, and supplier qualification as it relates to sterility assurance standards
  • Ensure QMS integration, deviation management, and inspection readiness
  • Chair monthly governance forums and drive strategic decisions
  • Build capability through Communities of Practice

Requirements

  • Bachelor’s degree in microbiology, life sciences, engineering, or related field, or equivalent experience
  • Significant experience in sterility assurance, microbiology, or quality in a regulated manufacturing environment
  • Proven leadership in cross-functional roles including QA, Engineering, and MSAT
  • Strong knowledge of Annex 1, GMP, and global regulatory requirements
  • Experience in inspection readiness

Benefits

  • health care and other insurance benefits (for employee and family)
  • retirement benefits
  • paid holidays
  • vacation
  • paid caregiver/parental and medical leave

Job title

Vice President – Sterility Assurance

Job type

Experience level

Lead

Salary

$225,000 - $375,000 per year

Degree requirement

Bachelor's Degree

Location requirements

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