Director of Quality
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 hands-on working-director role in a small, collaborative company: the Director sets the direction for Quality while remaining closely involved in day-to-day work alongside the team. The position reports directly to leadership and is part of the leadership team, with influence over how Quality is developed, operated, and embedded across the business. The Director leads QA, QC, and laboratory operations, oversees the Quality Management System and regulatory activities, and partners with Manufacturing, Operations, and other departments to build a culture of shared responsibility for quality. The role also involves working in laboratory and manufacturing areas, with minimal travel for occasional supplier audits or conferences. Compensation is a base salary up to $140,000 plus a leadership incentive program.
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 OTC drug or pharmaceutical.
- 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.
- Ability to work in laboratory and manufacturing areas and lift up to 25 lbs.
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, and directly manage a small, experienced team.
- Own, maintain, and improve the Quality Management System, including 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.
- Work with Manufacturing, Operations, and other departments to build a culture where quality is everyone’s responsibility.
- Lead continuous improvement efforts to reduce repeat issues, rework, and scrap and strengthen process control.
- Manage regulatory submissions, including product registrations and state licensure.
Benefits
- Medical, dental, and vision insurance.
- Domestic relocation assistance.
- Leadership incentive program.
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What This Job Offers
Job Type
Full-time
Career Level
Director
