Director, QMS Process Owner - Global Change Control Management

Ladders; United States; Remote; USD 168,000 - 228,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

401(k) plan with company contributions

FSA/HSA options

Life insurance and wellness programs

Paid time off

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

Quality leadership

Global Change Control ownership

GxP knowledge

Digital transformation

Regulatory collaboration

Education

Bachelor's degree in life sciences/engineering/quality

Advanced degree preferred

Job description

For our client, we are seeking a Director, QMS Process Owner - Global Change Control Management to join the team of a leader in the Pharmaceuticals & Biotech space.

This leader will oversee the global change control framework within a regulated life sciences environment, ensuring change management is consistent, risk-based, and aligned across products and sites. The role will partner closely with Regulatory Affairs, manufacturing, quality, and external collaborators to support implementation readiness and execution quality. In addition, this leader will drive process simplification, digital adoption, and performance insights that strengthen the quality system across the product lifecycle.

Location: Remote

Compensation: $168,000 – $228,000 annually

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 throughout the product lifecycle
• Partner with Regulatory Affairs to integrate regulatory commitments into change planning
• Coordinate complex global changes across multiple functions and external partners
• Establish strategic portfolio visibility for major changes across products and sites
• Own change management intelligence and analytics, including performance indicators and improvement priorities

Qualifications

• Bachelor's degree in life sciences, engineering, quality management, or a related field required; advanced degree preferred
• 10+ years of relevant experience in Quality Systems, Quality Operations, Technical Operations, Manufacturing, Regulatory Affairs, or a related GxP function in pharma or biotech
• Demonstrated ownership or senior leadership in Change Control or Variation Management in a global context
• Experience with new product introduction, technology transfer, and product lifecycle management strongly preferred
• Familiarity with QMS transformation, workflow design, and digital adoption preferred
• Lean, Six Sigma, project management, or quality risk management training or certification is a plus

Benefits

• Comprehensive medical, dental, and vision coverage
• 401(k) plan with company contributions
• Flexible spending accounts (FSA/HSA) available
• Life insurance and wellness programs offered
• Paid time off to support work-life balance
• Opportunities for equity ownership through discretionary awards and an employee stock purchase plan

Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.