Global Quality Transformation Director

HireLifeScience; West Point (PA); Hybrid; USD 210,000 - 331,000; Full time

Benefits offered by this job

Hybrid work arrangement

Bonus & incentives

Job summary

Merck seeks a seasoned Quality Leader to provide strategic oversight for a complex enterprise-level transformation in a GMP laboratory setting. You will align cross-functional teams, manage governance forums, and drive end-to-end execution from planning to regulatory filing and operational transition, ensuring strong compliance and measurable value.

The role requires a collaborative, data-driven leader with deep experience in analytical development, testing, and automation within regulated

Qualifications

• Bachelor's degree required; advanced degree (PhD, MBA, PharmD, or equivalent) strongly preferred
• 15+ years of experience in quality, pharmaceutical development, manufacturing, or related biopharmaceutical functions
• Leadership experience with CGMP testing laboratories subject to FDA inspections
• Experience implementing laboratory technology and digital lab components

Responsibilities

• Set strategic Quality direction and translate into an integrated, end-to-end program plan
• Direct governance, execution, and risk management across matrixed teams
• Collaborate with executive sponsors and delivery teams to enable timely decisions
• Drive technology transformation and operating model changes in GMP environments
• Ensure alignment with quality and regulatory requirements and successful regulatory filings

Skills

Strategic leadership

Analytical thinking

Stakeholder management

Project/program management

Risk management

Cross-functional collaboration

Communication to executives

GxP compliance

Budgeting/forecasting

Education

Bachelor's degree

PhD / MBA / PharmD or equivalent

Job description

Merck seeks a seasoned Quality Leader to provide strategic oversight for a complex enterprise-level transformation in a GMP laboratory setting. You will align cross-functional teams, manage governance forums, and drive end-to-end execution from planning to regulatory filing and operational transition, ensuring strong compliance and measurable value.

The role requires a collaborative, data-driven leader with deep experience in analytical development, testing, and automation within regulated