Product Quality Leader

Responsibilities

• Develop, maintain, and integrate end-to-end Product Quality Strategy for assigned assets from pivotal readiness through launch and lifecycle management
• Lead the Product Quality Team and influence cross-functional teams and strategic partners to align priorities, decisions, readiness plans, and accountable delivery
• Represent Quality as the One Quality Voice at senior governance forums
• Provide Quality leadership for pivotal, filing, launch, inspection, and post-approval readiness
• Provide strategic input to control strategy, comparability strategy, regulatory submissions, health-authority responses, PAI preparation, and critical quality controls
• Oversee Product Quality deliverables and milestone-readiness activities
• Drive product quality risk detection, assessment, governance, escalation, mitigation, and acceptance
• Coordinate matrix oversight of QMS and lifecycle processes, including changes, deviations, CAPAs, complaints, product quality reviews, validation, post-approval changes, dossiers, and regulatory submissions
• Drive end-to-end Product Quality for commercial Vaccines or Medicines through product, process, analytical, digital, and knowledge-management improvements
• Serve as global subject matter expert for new product introduction and product quality lifecycle change management
• Improve Product Quality Strategy processes, standards, governance frameworks, and organizational capability
• Translate complex risks into clear business recommendations and governance decisions
• Monitor product quality signals, complaint trends, deviations, CAPAs, product quality reviews, stability, and lifecycle information
• Drive communication, escalation, decision documentation, ownership, and follow-through for quality, compliance, regulatory, and supply risks
• Coach and develop colleagues through technical guidance, decision support, and knowledge sharing

• Bachelor’s degree
• Minimum 10 years of pharmaceutical-industry experience across Quality and/or Technical functions
• Experience in GMP
• Experience with product lifecycle management
• Experience with product quality risk management and new product introduction
• Experience with regulatory submissions and inspection readiness
• Matrix leadership experience
• Governance participation experience
• Master’s degree preferred
• Experience in more than one Quality or Technical role preferred
• Deep understanding of GMP, pharmaceutical quality systems, Quality Assurance and/or Quality Control, product lifecycle management, and global regulatory expectations
• Demonstrated enterprise leadership capability connecting quality decisions to patient impact, product strategy, supply continuity, regulatory outcomes, and business priorities
• Proven matrix leadership and stakeholder-influence skills, including resolving conflict, creating One Quality Voice, and driving delivery without direct line authority
• Strong product quality risk-management capability, scientific judgment, systems thinking, and ability to make or recommend decisions under uncertainty and ambiguity

Demonstrates extensive expertise in Product Quality Strategy, including risk management, regulatory submissions, and lifecycle management within the pharmaceutical industry. Proven ability to lead cross-functional teams and influence stakeholders while ensuring compliance and quality standards are met.

• Product Quality Strategy Development
• Regulatory Submissions Experience
• GMP Knowledge
• Matrix Leadership
• Product Lifecycle Management

• Product Quality Risk Management
• Quality Assurance
• Quality Control
• Governance Frameworks
• CAPA Management
• Analytical Improvements
• Digital Quality Management
• Health-Authority Responses
• Inspection Readiness
• Pivotal Readiness

• Stakeholder Influence
• Conflict Resolution
• Coaching and Development
• Decision Support
• Communication

• Bachelor’s Degree
• Master’s Degree Preferred

• Pharmaceutical Industry
• Quality Management System
• Product Quality Reviews
• Regulatory Expectations
• Lifecycle Processes