Senior Director, U.S. Quality

Galderma•Boston, MA

1d•Hybrid

About The Position

Whether it's the unique breadth of our integrated offering that covers Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology products; or our commitment to recognizing and rewarding people for the contribution they make - working here isn't like anywhere else. At Galderma, we actively give our teams reasons to believe in our 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. 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 role Leads a major functional area within a key market (U.S.), with significant impact on business operations and compliance outcomes. It Implements and operationalizes global strategies within the region. It 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.

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

Drive implementation of the Quality Management strategy across the U.S., ensuring alignment with global quality objectives and consistent execution across operations.
Adapt and implement global quality policies, processes, and systems to meet U.S. regulatory and business requirements.
Ensure compliance with FDA and applicable regulatory requirements; lead U.S. inspection readiness and support regulatory interactions and audits.
Champion continuous improvement across quality systems, including CAPA, deviations, complaints, and audit readiness.
Identify, assess, and mitigate quality and compliance risks; lead cross-functional efforts to resolve complex quality issues.
Ensure effective implementation and ongoing performance of Quality Management Systems (QMS), including SOPs, policies, and metrics.
Lead and develop a high-performing Quality organization, typically through senior managers and managers, fostering strong leadership capability and accountability.
Manage the U.S. Quality budget, ensuring resources are effectively allocated to support compliance and business priorities.
Partner with Manufacturing, Supply Chain, R&D, Regulatory Affairs, and Commercial teams to ensure integrated and compliant quality practices.
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.