Senior Director, Quality, Americas

Sunstar Americas, Inc.•Schaumburg, IL

10d•$210,000 - $250,000•Hybrid

About The Position

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.

Requirements

Bachelor's degree in Science, Engineering, Quality, Life Sciences, or related discipline required.
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

Nice To Haves

Advanced degree preferred.
additional languages are a plus: Japanese, Chinese, French.

Responsibilities

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.
Drive continuous improvement initiatives.
Lead, coach and develop the Americas quality team.
Build organizational capabilities through training and mentoring.
Manage quality resources and budgets.

Benefits

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-site café
On Site Fitness Center
Corporate Perks Discount Program (Auto, Retail, Electronics, Entertainment, Computers, Personal Vacations, Cell Phones, Movie Tickets, Eating Out and Much More)
Holiday Lunches
Beautifully maintained walking trails
Numerous employee appreciation events throughout the year.
Recognition and Rewards Programs