Senior Director, Quality Americas

Sunstar Americas, Inc. is a global leader in the oral care industry and the manufacturer and distributor of GUM oral care products and solutions. Formerly known as the John O. Butler Company, we are renowned for our exceptional production and distribution, and high-quality oral care products. With our headquarters in Schaumburg, Illinois, and branches in Canada, Mexico, Colombia, Brazil, and Argentina, as well as distribution partners in Central and South America, we have established ourselves as an industry leader.

Position Summary

The 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.

• 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.

• 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.

• Identify and mitigate quality-related risks.
• Support new product development and commercialization.
• Oversee quality throughout the product lifecycle.

• Lead supplier qualification and audit programs.
• Support global registrations through technical documentation.
• Manage audits, inspections and CAPA programs.

• Partner with Manufacturing, R&D, Supply Chain, Procurement and Commercial teams.
• Lead investigations of complaints and quality events.

• Lead, coach and develop the Americas quality team.
• Build organizational capabilities through training and mentoring.
• Manage quality resources and budgets.

• 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.
• 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.

Why Work at Sunstar? Sunstar’s mission is to enhance the health and well-being of people everywhere via its four business areas: mouth and body, health and beauty, healthy home, safety and technology.

• A business focused on health and wellness of people around the world
• High Quality Products
• Beautiful state-of-the-art facility
• Diversity and Inclusion
• Corporate Social Responsibility Program and partnership with charitable organization
• Strong value placed on company culture
• Excellent, comprehensive insurance coverage that includes Medical, Vision, and Dental benefits.
• Opportunities for career growth and advancement
• Employee discount on Sunstar products
• 401K retirement plan with employer match (Pretax and Roth options)
• 401K profit sharing contribution based on company performance.
• Paid holidays and generous paid time off. Pet, Legal and Identity Theft Insurance Plans
• Competitive bonus
• On…