We’re more than a company—we’re a collaborative team driven by integrity, growth, and continuous improvement. Here, you’ll have the opportunity to work cross-functionally and make an immediate impact, and to grow your career in a mission driven organization.
Our foundation is built on three core pillars:
- Trusted: We create and maintain positive relationships through transparency and integrity, establishing trust through our commitment to provide quality service and science-backed products.
- Compassionate: We understand oral health complexity and recognize the difficulties clinicians and patients experience. By listening to their needs, we deliver a treatment model to improve people’s lives using pH targeted products.
- Education-Focused: We foster partnerships by engaging and educating people on effective oral health and wellness strategies.
What We Offer
In addition to a culture of collaboration and growth, we provide:
- 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
If you enjoy solving problems, working in dynamic environment, and growing alongside a team that cares about its work, we’d love to hear from you!
To learn more about who we are and what we do, visit carifree.com/carifree-difference/
Position: Director of Quality and Regulatory Assurance
Job Summary
The Director of Quality and Regulatory Assurance oversees Oral BioTech’s quality department and regulatory strategy. The Director ensures alignment with applicable FDA regulations and cGMP requirements, across drugs, devices, cosmetics, and food regulatory standards. They are responsible for providing strategic oversight of the Quality Unit, encompassing both Quality Assurance and Quality Control, and reports directly to the CEO. Building on an established quality foundation, they deliver higher level regulatory interpretation and quality system oversight to ensure sustained compliance and long-term readiness. The Director works collaboratively across departments to promote consistent process control and acceptable product quality.
Supervisory 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.
Duties/Responsibilities
- 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.
Required Skills and Abilities
- Bachelor’s degree in Chemistry, Biology, Engineering, or a related scientific field (Master’s degree preferred).
- 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.
- Certifications such as Quality Auditor (CQA), Six Sigma, or LEAN are a plus.
Physical Requirements
- Ability to lift 25 lbs.
- Ability to sit and stand for long periods.
- · Occasional bending, stooping, kneeling, reaching, and walking in laboratory and manufacturing areas.