Senior Director, U.S. Quality

Galderma•Boston, MA

1d•Hybrid

About The Position

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. They 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 their foundation in 1981, Galderma has dedicated its 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. The company looks for people who focus on getting results, embrace learning and bring a positive energy, combining initiative with a sense of teamwork and collaboration, and are passionate about doing something meaningful for consumers, patients, and healthcare professionals. Galderma aims to empower each employee and promote their personal growth while ensuring business needs are met, embracing diversity and respecting the dignity, privacy, and personal rights of every employee. 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. This position leads a major functional area within the U.S. market, with significant impact on business operations and compliance outcomes, implements and operationalizes global strategies within the region, and contributes to functional strategy through regional insights and execution excellence. The impact is primarily within the region, with alignment to global objectives, and the time horizon is 1–3 years, focused on execution, optimization, and continuous improvement.

Requirements

14+ years of progressive experience in Quality within pharmaceutical/biotech or related industry
Demonstrated leadership experience managing teams and complex operations
Strong knowledge of U.S. regulatory requirements (FDA, GxP)
Proven ability to execute strategy and drive operational excellence
Strong collaboration, influencing, and problem-solving skills

Nice To Haves

Advanced degree (Master’s or PhD) in a relevant scientific or technical discipline preferred

Responsibilities

Lead U.S. Quality Execution: 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.
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.
Influences stakeholders to drive alignment and ensure quality and compliance objectives are achieved.