Senior Director, U.S. Quality

GaldermaBoston, MA
Hybrid

About The Position

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. 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.

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.
  • 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

Benefits

  • competitive and comprehensive benefits program including health insurance
  • 401(k) plan with employer match
  • generous paid time off policy
  • hybrid work schedules
  • competitive wage with shift differential
  • annual bonus opportunities
  • career advancement
  • cross-training
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