Job SummaryThe 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.
Key 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.
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
Skills & Qualifications- 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
- Advanced degree (Master's or PhD) in a relevant scientific or technical discipline preferred
About the Compensation:The base salary range for this role is determined based on several factors. These include but are not limited to job accountabilities; skill sets; experience and training; certifications; work location; competitive market rates and other business needs. At Galderma, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on a unique combination of factors for each role. A reasonable estimate of the hiring range for this role is $215,000-$260,000 USD.
In addition to base salary, we provide an opportunity to participate in an annual short-term incentive program that is based on corporate performance with a multiplier focused on individual performance. We offer a competitive and comprehensive benefits program including health insurance, 401(k) plan with employer match, a generous paid time off policy, hybrid work schedules and more.
What we offer in returnYou will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base. You will also have access to a range of company benefits, including a competitive wage with shift differential, annual bonus opportunities and career advancement and cross-training.
Next Steps- If your profile is a match, we will invite you for a first virtual conversation with the recruiter.
- The next step is a virtual conversation with the hiring manager
- The final step is a panel conversation with the extended team