Position SummaryThe SUNSTAR Consumer Quality organization is responsible for ensuring product quality, regulatory compliance, consumer safety, and continuous improvement across the entire product lifecycle. The Senior Director, Quality co-develops and executes the global quality strategy and quality management system, ensuring compliance with FDA, QSR, cGMP, and applicable international regulations in the Americas region.
Key Responsibilities: Quality Strategy & Governance- Develop and execute the Americas quality strategy aligned with business objectives and corporate priorities.
- Provide leadership for quality functions across all relevant facilities and markets.
- Establish and monitor quality KPIs and metrics.
Quality Management Systems & Compliance- Lead the continuous improvement of the Quality Management System.
- Ensure compliance with FDA, QSR, cGMP, ISO requirements and applicable regulations.
- Maintain inspection and certification readiness.
Quality Risk & Product Lifecycle Management- Identify and mitigate quality-related risks.
- Support new product development and commercialization.
- Oversee quality throughout the product lifecycle.
Supplier Quality & Regulatory Affairs- Lead supplier qualification and audit programs.
- Support global registrations through technical documentation.
- Manage audits, inspections and CAPA programs.
Stakeholder Collaboration & Operational Excellence- Partner with Manufacturing, R&D, Supply Chain, Procurement and Commercial teams.
- Lead investigations of complaints and quality events.
- Drive continuous improvement initiatives.
Leadership & Talent Development- Lead, coach and develop the Americas quality team.
- Build organizational capabilities through training and mentoring.
- Manage quality resources and budgets.
Qualifications & Experience- Bachelor's degree in Science, Engineering, Quality, Life Sciences, or related discipline required. Advanced degree preferred.
- Minimum 10 years in Quality leadership roles within regulated industries e.g. oral care.
- Proven track record of exceeding quality and business objectives.
- Strong experience with FDA, QSR, cGMP, ISO 13485 , ISO 9001 and international regulations.
- Excellent communication, influencing, and stakeholder management abilities.
- Language: Fluent in English, additional languages are a plus: Japanese, Chinese, French.
Key Competencies- Quality and regulatory excellence
- Risk management and problem-solving
- Strategic and analytical thinking
- Executive communication and stakeholder influencing skills
- Change leadership and talent development
- Results orientation and accountability
- Collaboration and relationship management
- Business and financial acumen
- Agility and adaptability, continuous improvement mindset
Join us and become part of our global team, where together, we can achieve success and contribute to a better future.
If you'd enjoy a career helping others attain overall health through oral health, consider joining the Sunstar Americas, Inc. team.
The pay range for this position of Senior Director, Quality is $210,00- $250,000. However, base pay offered may vary depending on skills, experience, job-related knowledge and location. This position is also eligible for an annual bonus as part of total compensation
