Quality Transformation Lead Job Collegeville area,Pennsylvania USA,Quality Assurance

Lead assigned ESOQ quality transformation programs and work streams
Drive inspection readiness for external CMO/supplier inspections, internal inspections, self-inspections, and RQA audit readiness
Coordinate annual audit and self-inspection planning, readiness tracking, remediation, lessons learned, and follow-up
Drive the ESOQ Gemba process and translate observations into sustainable improvements
Implement new ways of working, capability building, stakeholder engagement, and proactive quality culture initiatives
Drive cross-network learning from inspections, audits, and CAPAs into preventive actions
Develop and communicate compliance, inspection-readiness, remediation, and transformation KPI reporting
Drive CAPA closure and effectiveness verification across ESOQ, Site QA, and CMO QA
Apply Quality Risk Management to compliance, quality systems, process changes, and transformation initiatives
Lead continuous improvement using lean, risk-based, and data-driven approaches
Design and implement AI and digital transformation solutions in quality processes
Partner with leadership and cross-functional stakeholders to assess readiness and drive adoption
Develop and execute change, communication, and training strategies
Lead governance routines, milestone tracking, issue and risk management, and execution reporting
Support audit and inspection response activities, management reporting, CAPA follow-up, and trend analysis
Benchmark internal and external best practices and integrate relevant learnings
Provide leadership through influence, collaboration, and subject matter expertise
Lead end-to‑end change management for transformation initiatives
Identify, prioritize, and implement AI use cases supporting compliance, inspection readiness, knowledge management, efficiency, and decision‑making
Lead program governance, business process optimization, roadmap delivery, portfolio reporting, and transformation execution

Requirements

Bachelor's degree with at least 8 years of experience; OR master's degree with at least 7 years of experience; OR PhD with 5+ years of experience
Significant pharmaceutical or life sciences industry experience
Substantial exposure to quality, compliance, inspection readiness, and/or operational excellence in regulated environments
Strong working knowledge of GMP/GDP requirements, global regulatory expectations, and inspection practices
Experience supporting or preparing for regulatory inspections, audits, and quality system oversight
Experience leading complex, cross‑functional transformation initiatives with measurable impact
Experience across inspection readiness and audit lifecycle activities
Ability to apply Quality Risk Management and structured problem‑solving approaches
Experience developing and using metrics/KPI reporting and governance frameworks
Strong program and project management capabilities
Ability to manage multiple initiatives, prioritize workload, and drive execution through governance routines
Ability to influence and align global, cross‑functional, and matrixed organizations and senior stakeholders
Strong communication, facilitation, and stakeholder engagement skills
Experience leading change management for complex transformation initiatives
Preferred: experience with external supply networks, CMOs, suppliers, and global third‑party partners
Preferred: continuous improvement methodologies such as Lean, Six Sigma, DMAIC, IMEx, or OPEX
Preferred: business transformation, PMO, governance models, portfolio management, and milestone tracking
Preferred: digital and AI‑enabled transformation within quality systems
Preferred: regulatory inspection Front Office/Back Office operations, SME coordination, document management, inspection war rooms, and real‑time issue resolution
Preferred: experience with eQMS, SAP, Track Wise, Vault, Documentum, or comparable systems
Up to 20% travel
Non‑standard work hours may apply
Candidates must be authorized to be employed in the U.S. by any employer
Permanent work authorization in the United States is required
U.S. work visa sponsorship is not available now or in the future

Core Competencies

Demonstrates expertise in Quality Risk Management, compliance, and inspection readiness…