Director of Quality

Keller Executive Search • Tangent, OR

2d

About The Position

A well-established FDA-regulated manufacturer of OTC drug and personal care products is seeking a Director of Quality to lead its Quality Assurance and Quality Control functions. This is a working director role in a small, collaborative company, combining strategic direction-setting with hands-on involvement in daily work. The position reports directly to leadership and is part of the leadership team, with influence over how Quality is built, managed, and embedded across the business.

The Director leads QA, QC, and laboratory operations; oversees the Quality Management System and regulatory activities; and works closely with Manufacturing, Operations, and other departments to promote shared ownership of quality. The role uses a practical, risk-based approach to meet regulatory requirements and business needs. Travel is minimal, with occasional supplier audits or conferences. The position requires time in laboratory and manufacturing areas and the ability to lift up to 25 pounds.

Requirements

• Bachelor’s degree in Chemistry, Biology, Engineering, or a related scientific or quality/regulatory field.
• At least 7 years of quality leadership experience in an FDA-regulated manufacturing environment, ideally in OTC drugs or pharmaceuticals.
• Strong working knowledge of cGMP and 21 CFR 210/211.
• Hands-on experience with FDA inspections before, during, and after the inspection.
• Strong command of investigations, root cause analysis, deviations, batch production records, material disposition, and CAPA.
• Strong technical writing and documentation skills.
• Collaborative, approachable leadership style and a track record of developing high-performing teams.
• Self-directed, proactive approach and comfort working hands-on alongside the team.

Nice To Haves

• Master’s degree or MBA.
• Exposure to 21 CFR 820, cosmetic, or food regulations.
• Experience with an electronic QMS.
• CQA, Six Sigma, or Lean certification.

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.
• Serve as the company’s primary regulatory contact and designated representative during FDA inspections.
• Oversee batch record review, material disposition, and testing strategy for raw materials, in-process materials, and finished goods.
• Lead Management Review, product quality reviews (PQRs), and trend reporting to executive leadership.
• Develop and manage the Quality department budget.
• Apply a practical, risk-based approach that balances regulatory requirements with business needs.
• Build a culture where quality belongs to everyone, working closely with Manufacturing, Operations, and other departments.
• Lead continuous improvement efforts to reduce repeat issues, rework, and scrap and strengthen process control.
• Manage regulatory submissions, such as product registrations and state licensure.

Benefits

• Competitive base salary up to $140,000 plus a leadership incentive program.
• Medical, dental, and vision insurance.
• Domestic relocation assistance.

What This Job Offers

• Job Type: Full-time
• Career Level: Director