Remote Director, Global QMS Change Control
Ladders
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Benefits offered by this job
Job summary
Ladders is seeking a Director, QMS Process Owner - Global Change Control Management to lead the global change control framework in a regulated life sciences environment. The role partners with Regulatory Affairs, manufacturing, quality, and external collaborators to ensure readiness, execution quality, and continuous improvement.
The remote-position leader will drive process simplification, digital adoption, and performance insights across the product lifecycle, ensuring risk-based decisions
Qualifications
- 10+ years leading Quality Systems or Change Control in pharma/biotech.
- Experience in global Change Control or Variation Management.
- Familiarity with QMS transformation and digital adoption.
Responsibilities
- Own the global GxP change management strategy and operating model.
- Lead risk-based simplification and digital transformation of the change control process.
- Oversee implementation readiness, execution quality, and effectiveness evaluation.
- Develop harmonized change management pathways across the product lifecycle.
- Partner with Regulatory Affairs to integrate regulatory commitments into change planning.
- Coordinate complex global changes across functions and external partners.
- Establish strategic portfolio visibility for major changes across products/sites.
- Own change management analytics, including performance indicators and priorities.
Skills
Education
Job description
Ladders is seeking a Director, QMS Process Owner - Global Change Control Management to lead the global change control framework in a regulated life sciences environment. The role partners with Regulatory Affairs, manufacturing, quality, and external collaborators to ensure readiness, execution quality, and continuous improvement.
The remote-position leader will drive process simplification, digital adoption, and performance insights across the product lifecycle, ensuring risk-based decisions
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