CariFree · 19 hours ago
Director of Quality and Regulatory Assurance
Tangent, OR
Full-time
Onsite
Lead/Staff, Director/Executive
5+ years expOral BioTech is a company that manufactures CariFree®, a line of mouthwash and toothpaste designed to improve oral health outcomes. The Director of Quality and Regulatory Assurance oversees the quality department and regulatory strategy, ensuring alignment with FDA regulations and cGMP requirements while promoting consistent process control and acceptable product quality.
Health CarePharmaceutical
Hiring Manager
Cody C.
Responsibilities
Drives organizational ownership of quality through leadership, engagement, and reinforcement of quality expectations at all levels of the company
Participates in leadership planning to align quality strategy with company goals
Provides oversight and strategy to the Quality Unit, which includes Quality Assurance and Quality Control staff
Oversees third party regulatory consultants and recommends when external regulatory expertise is needed to support compliance, inspections, or strategic objectives
Provides oversight of the Quality Management System
Serves as the designated company representative during FDA inspections, including communication, coordination of responses, and actionable responsibilities
Partners with HR and leadership to recruit, onboard, develop, and retain skilled quality professionals
Conducts performance reviews and supports coaching and employee growth planning
Manages discipline and termination of employees in accordance with company policy
Fosters a positive workplace culture to support company business initiatives
Maintains, updates, and improves the company’s Quality Management System (QMS) to ensure alignment with FDA regulations across drugs, devices, cosmetics, foods, and other applicable standards
Provides strategic oversight and ongoing assessment of QMS elements, including: Quality control and assurance, documentation systems, training, change control, risk management, CAPA, supplier quality, manufacturing and laboratory controls, complaint handling, internal audits, and inspection readiness
Leads regulatory strategy, product quality reviews, and compliance interpretation across departments
Provides independent quality authority over change control decisions impacting product quality, regulatory compliance, and patient safety
Serves as the internal regulatory expert and primary contact for FDA and other regulatory bodies
Leads formal Management Review processes to evaluate QMS effectiveness against performance metrics, compliance risks, and continuous improvement efforts
Oversees document control, SOP development/revisions, and system-wide quality documentation
Provides oversite and leadership for quality investigations, customer complaints, CAPAs, and risk mitigation
Oversees product testing strategies, including raw material, in-process, and finished goods, to ensure conformance to quality specifications
Manages internal and external audits, mock inspections, and third-party quality assessments
Oversees supplier qualification, monitoring, and risk management strategies for raw materials, components, and external service providers
Leads the regulatory submission process for product registrations and state licensure for manufacturing and distribution
Reviews and presents annual product quality reports (PQRs) and trend data to Executive Leadership
Develops and manages the Quality department budget to support quality operations and strategic growth
Oversees complaint trending and adverse event evaluation to identify emerging risks and systemic issues
Ensures data integrity in both electronic system controls and physical documentation
Collaborates cross-functionally with other departments and Executive Leadership to support organizational goals
Other responsibilities as designated by management
Qualification
Required
Bachelor's degree in Chemistry, Biology, Engineering, or a related scientific field
5+ years of experience in a quality leadership role within an FDA-regulated environment
Strong working knowledge of cGMP, QMS, 21 CFR 210/211/820, and related regulatory frameworks
Experience with regulatory agency inspections and communication
Demonstrated ability to lead and mentor high performing teams
Excellent problem-solving and critical thinking skills
Strong communication skills across levels and functions
Proficient with Microsoft Office and quality management systems
Preferred
Master's degree
Certifications such as Quality Auditor (CQA), Six Sigma, or LEAN
Benefits
Competitive Compensation
Profit-Sharing Bonus
Comprehensive Benefits (Medical, Dental, Vision, Life)
Work-Life Balance
11 Paid Holidays
Vacation and Sick Time
IRA with an Employer Contribution
Potential Relocation Assistance
Company
CariFree
CariFree offers science-based solutions and products to treat bacterial imbalance in the mouth to fight cavities.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Kim Kutsch
CEO
Company data provided by crunchbase