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. With 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.
About the role
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.
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.
Requirements
- 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.
- Fluent in English; additional languages (Japanese, Chinese, French) are a plus.
Skills
- Quality and regulatory excellence
- Risk management and problem-solving
- Strategic and analytical thinking
- Executive communication and stakeholder influencing
- Change leadership and talent development
- Results orientation and accountability
- Collaboration and relationship management
- Business and financial acumen
- Agility and adaptability, continuous improvement mindset
Benefits
- Comprehensive insurance coverage (Medical, Vision, Dental)
- 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-site café and fitness center
- Corporate Perks Discount Program (Auto, Retail, Electronics, Entertainment, Computers, Personal Vacations, Cell Phones, Movie Tickets, Eating Out, and more)
- Beautifully maintained walking trails
- Numerous employee appreciation events throughout the year
- Recognition and Rewards Programs
- Employee discount on Sunstar products
Pay
The pay range for this position is $210,000 - $250,000. 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.