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. For all positions, whether with Keller Executive Search or our clients, qualified applicants will receive consideration for employment without regard to race, skin color, religion, sex, sexual orientation, gender identity, gender expression, national origin, age, protected veteran status, disability, genetic information, or any other legally protected status.

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Reasonable Accommodations: Both Keller Executive Search and our clients are committed to providing reasonable accommodations to individuals with disabilities and pregnant individuals. We engage in an interactive process to determine effective, reasonable accommodations.

Compensation Information: For client positions, compensation information is available in the job post. If not provided, it will be shared during the interview process in accordance with applicable laws. When required by law, salary ranges will be included in job postings. Actual salary may depend on skills, experience, and comparison to current employees in similar roles. Salary ranges may vary based on role and location.

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• Colorado, Nevada, New York City, California, and Washington Residents: Compensation information is available in the job post or will be provided during the interview process if not initially available.
• Both Keller Executive Search and our clients are committed to pay equity and conduct periodic pay equity analyses in accordance with applicable laws.

State-Specific Information:

• Rhode Island: We do not request or require salary history from applicants.
• Connecticut: We provide wage range information upon request or before discussing compensation.
• New Jersey: We do not inquire about salary history unless voluntarily disclosed.

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Use of Artificial Intelligence in Recruitment

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Genetic Information: In accordance with federal and state laws, both Keller Executive Search and our clients do not discriminate based on genetic information. We do not request or require genetic information from applicants or employees, except as permitted by law.

Local Laws: Both Keller Executive Search and our clients comply with all applicable local laws and ordinances regarding employment practices in the areas where we operate.

Note: This job posting may be for a position with Keller Executive Search or one of our clients. The specific employer will be identified during the application and interview process. Employment laws and requirements may vary depending on the employer and location.