Director of Quality

Location: Tangent, United States Our client, a well-established FDA-regulated manufacturer of OTC drug and personal care products, is looking for a Director of Quality to lead its Quality Assurance and Quality Control functions. This is a working director role in a small, collaborative company. You’ll set the direction for Quality, and you’ll also stay close to the daily work alongside your team. The role reports directly to leadership and holds a seat on the leadership team, so you’ll have real influence over how Quality is built, run, and embedded across the business. If you want more autonomy and impact, this role offers both. What You’ll Do 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 primary regulatory contact and designated representative during FDA inspections Oversee batch record review, material disposition, and testing strategy for raw materials, in-process, 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 the needs of the business Build a culture where quality belongs to everyone, working closely with Manufacturing, Operations, and other departments Lead continuous improvement efforts that reduce repeat issues, rework, and scrap and strengthen process control Manage regulatory submissions such as product registrations and state licensure Additional Details Minimal travel (occasional supplier audit or conference) Requires time in laboratory and manufacturing areas and the ability to lift up to 25 lbs Requirements Bachelor’s degree in Chemistry, Biology, Engineering, or a related scientific or quality/regulatory field (Master’s or MBA a plus) 7+ years of quality leadership experience in an FDA-regulated manufacturing environment, ideally OTC drug or pharmaceutical Strong working knowledge of cGMP and 21 CFR 210/211; with exposure to 21 CFR 820, cosmetic, or food regulations Direct, hands-on experience with FDA inspections before, during, and after the inspection itself A strong command of quality events: investigations, root cause analysis, deviations, batch production records, material disposition, and CAPA Strong technical writing and documentation skills A collaborative, approachable leadership style and a track record of developing high-performing teams A self-directed, proactive approach and comfort working hands-on alongside your team Experience with an electronic QMS; CQA, Six Sigma, or Lean certification is a plus Benefits Competitive base salary up to $140k plus leadership incentive program Medical, dental, and vision insurance Domestic relocation assistance Equal Employment Opportunity and Non-Discrimination Policy Equal Employment Opportunity Statement: Both Keller Executive Search and our clients are Equal Opportunity Employers. 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