Find & Apply For Quality Control Systems Manager Jobs in Tangent, Oregon

Join Our Team at Oral BioTech as our Director of Quality. If you're passionate about quality and want your work to have a real impact, we'd love to talk with you! At Oral BioTech, we manufacture CariFree®, a science-based line of mouthwash and toothpaste designed to improve oral health outcomes. Our products include FDA-regulated OTC drugs, cosmetics, and other consumer oral care products used by dentists and patients every day. As our Director of Quality, you'll lead our Quality Department and help shape how quality and compliance are applied across the organization. You'll ensure our products and processes meet FDA, cGMP, and other applicable regulatory requirements while applying thoughtful, risk-based decision-making appropriate to OTC and consumer health products. We're looking for a leader with experience in OTC drugs, oral care, cosmetics, personal care, or similar FDA-regulated consumer products. You'll provide practical regulatory guidance, help teams understand and manage risk, and support continuous improvement while protecting product quality and maintaining strong compliance. Oral BioTech is a growing organization where teams work closely together and leaders are involved in the day-to-day business. You'll work across departments, directly influence our approach to quality and compliance, and help us keep improving how we work. 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 Comprehensive Benefits (Medical, Dental, Vision, Life) Work-Life Balance 11 Paid Holidays Vacation and Sick Time IRA with an Employer Contribution Potential Relocation Assistance 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: https://carifree.com/carifree-difference.

Job Summary:

The Director of Quality oversees Oral BioTech's Quality Department with primary responsibility compliance for our OTC drug and cosmetic products across professional and consumer oral care. The Director ensures alignment with applicable FDA regulations, cGMP requirements, and other relevant drug, cosmetic, device, and food regulatory standards. This role provides 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, the Director provides regulatory interpretation and quality system leadership while applying a practical, risk-based approach appropriate to our products and manufacturing environment.

Supervisory Responsibilities:

Drives organizational ownership of quality through leadership and engagement of quality expectations at all levels of the company. Participates in leadership planning to align quality strategy with company goals, working collaboratively across departments. 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, applying a practical, risk-based approach appropriate to the company's products and operations. 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, product and compliance risks, and continuous improvement efforts. Oversees document control, SOP development/revisions, and system-wide quality documentation appropriate to applicable regulatory requirements and product risk. 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.

Skills and Qualifications:

Bachelor's degree in Chemistry, Biology, Engineering, or a related scientific field (Master's degree a plus). 5+ years of experience in a quality leadership role within an FDA-regulated environment. Strong understanding of c

GMP, 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 sit or stand for extended periods. Ability to lift up to 25 pounds. Occasional bending, stooping, kneeling, reaching, and walking in laboratory and manufacturing areas.

Pay:

$100,000.00 - $120,000.00 per year

Benefits:

Dental insurance Health insurance Life insurance Paid time off Retirement plan Vision insurance Application Question(s): Describe your experience with cGMP requirements, Quality Management Systems, and FDA regulations including 21 CFR 210, 211, and 820? Are you able and willing to relocate, or commute to Tangent, OR 97389 or Albany, OR 97321, or surrounding areas, as this is an on-site position? Do you have 5+ years of experience in a quality leadership role within a regulated manufacturing environment? Pharma, OTC-Drug, Cosmetic, Food. Please Describe.

Education:

Bachelor's (Required)

Work Location:

In person