Director of Quality - Hands-On FDA-Regulated Leader

Keller Executive Search; Tangent (OR); On-site; USD 126,000 - 154,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Domestic relocation assistance

Competitive base salary

Job summary

Keller Executive Search client, a FDA-regulated manufacturer of OTC drug and personal care products, seeks a Director of Quality to lead QA and QC. This is a working director role in a small, collaborative company with direct access to leadership and a seat on the leadership team.

You will own the Quality Management System, supervise QA/QC and labs, guide regulatory inspections, and drive CAPA, deviations, and continuous improvement with hands-on, cross-functional leadership.

Qualifications

• 7+ years of quality leadership experience in an FDA-regulated manufacturing environment.
• Strong working knowledge of cGMP and 21 CFR 210/211; exposure to 21 CFR 820, cosmetic, or food regulations.
• Direct, hands-on experience with FDA inspections before, during, and after the inspection.
• Experience with regulatory submissions such as product registrations and state licensure.

Responsibilities

• Lead the Quality unit, including QA, QC, and laboratory operations, with direct leadership of a small, experienced team.
• Own, maintain, and improve the Quality Management System across document control, training, change control, CAPA, deviations, investigations, supplier quality, complaint handling, and internal audits.
• Drive open CAPA and regulatory response activities to timely, effective closure.
• Act as the company’s regulatory contact during FDA inspections.
• Oversee batch record review, material disposition, and testing strategy for materials and finished goods.
• Lead Management Review, product quality reviews (PQRs), and trend reporting to executive leadership.
• Develop and manage the Quality department budget.
• Build a culture where quality belongs to everyone and work closely with Manufacturing and Operations.

Skills

Quality leadership

FDA inspections

cGMP knowledge

Technical writing

Regulatory liaison

Cross-functional leadership

Education

Bachelor's degree in Chemistry, Biology, Engineering

Tools

Electronic QMS

Job description

Keller Executive Search client, a FDA-regulated manufacturer of OTC drug and personal care products, seeks a Director of Quality to lead QA and QC. This is a working director role in a small, collaborative company with direct access to leadership and a seat on the leadership team.

You will own the Quality Management System, supervise QA/QC and labs, guide regulatory inspections, and drive CAPA, deviations, and continuous improvement with hands-on, cross-functional leadership.