Drive implementation of the Quality Management strategy across the U.S., ensuring alignment with global quality objectives and consistent execution across operations.
Translate Global Strategy into U.S. Operations
Adapt and implement global quality policies, processes, and systems to meet U.S. regulatory and business requirements.
Regulatory & Compliance Leadership
Ensure compliance with FDA and applicable regulatory requirements; lead U.S. inspection readiness and support regulatory interactions and audits.
Operational Excellence & Continuous Improvement
Champion continuous improvement across quality systems, including CAPA, deviations, complaints, and audit readiness.
Risk Management & Issue Resolution
Identify, assess, and mitigate quality and compliance risks; lead cross-functional efforts to resolve complex quality issues.
Quality Systems Oversight
Ensure effective implementation and ongoing performance of Quality Management Systems (QMS), including SOPs, policies, and metrics.
Leadership & Team Development
Lead and develop a high-performing Quality organization, typically through senior managers and managers, fostering strong leadership capability and accountability.
Financial & Resource Management
Manage the U.S. Quality budget, ensuring resources are effectively allocated to support compliance and business priorities.
Cross-Functional Collaboration
Partner with Manufacturing, Supply Chain, R&D, Regulatory Affairs, and Commercial teams to ensure integrated and compliant quality practices.
External Engagement
Support interactions with regulatory authorities and external partners as needed.
Differentiator
Leads a major functional area within a key market (U.S.), with significant impact on business operations and compliance outcomes
Implements and operationalizes global strategies within the region
Contributes to functional strategy through regional insights and execution excellence
Impact is primarily within region, with alignment to global objectives
Time horizon: 1-3 years, focused on execution, optimization, and continuous improvement
Typically reports to Global Head of Quality
Management Responsibility
Leads teams primarily through senior managers and managers; may include limited director-level oversight depending on structure
Accountable for organizational effectiveness, talent development, and succession planning within U.S. Quality
Develops and executes operational plans (1-3 years) aligned with global strategy
Budget accountability for U.S. Quality
Stakeholders
U.S. business leaders and Global Quality leadership
Regulatory authorities (e.g., FDA)
Cross-functional partners across Technical Operations, R&D, Commercial, and Supply Chain
Influences stakeholders to drive alignment and ensure quality and compliance objectives are achieved
Requirements
14+ years of progressive experience in Quality within pharmaceutical/biote
Benefits
Health insurance
Additional Information
Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story.
We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.
At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.
Job Summary
The Senior Director, U.S. Quality is responsible for leading and executing the Quality Management strategy across the U.S. business, ensuring compliance, operational excellence, and continuous improvement across all quality systems, processes, and products.
This role partners closely with Global Quality leadership to translate enterprise quality frameworks into effective U.S.-specific execution, ensuring alignment with regulatory requirements, business objectives, and patient safety standards.
Galderma · Boston