Director of Quality and Regulatory Affairs
Director, Quality & Regulatory Affairs
Elgin, IL | On‑Site (5 days/week)
OTC Drug & Consumer Health Manufacturing
Full‑Time | Senior QA Leadership Role
An established OTC drug and consumer health manufacturer is seeking a Director of Quality & Regulatory Affairs to lead site‑level QA and regulatory activities within a fast‑paced manufacturing environment. This is a QA‑first, hands‑on leadership role focused on stabilizing quality systems, strengthening FDA readiness, and building consistent execution across operations.
The role is best suited for a quality leader who has owned outcomes under regulatory pressure, can build systems that scale, and knows how to partner with Operations to move away from reactive, fire‑driven quality.
Key Responsibilities
Site Quality Leadership
- Own site‑level Quality Systems end to end (QMS, deviations, CAPA, change control)
- Serve as the primary quality leader supporting manufacturing, laboratories, and validation
- Drive accountability, structure, and predictability across QA operations
- Lead and develop teams across QA, validation, microbiology, and chemistry
FDA & Compliance
- Lead FDA inspection readiness, execution, and response
- Drive remediation of legacy gaps and ensure sustained compliance
- Ensure procedures and systems evolve with changing regulatory expectations
- Oversee audit preparation and response for customer and regulatory inspections
Microbiology & Technical Oversight
- Provide leadership and credibility across microbiology programs
- Oversee water systems, environmental monitoring, and contamination control
- Ensure risk‑based decision making for product disposition and release
Operations Partnership
- Partner closely with Operations to align on safety, quality, delivery, and cost
- Move the organization away from "QA vs Ops" toward shared goals
- Establish clear expectations, roles, and handoffs to reduce reactivity and delays
Systems & Continuous Improvement
- Build and enforce systems rather than relying on individual heroics
- Ensure teams execute consistently against defined procedures
- Improve on‑time delivery, inspection outcomes, and overall quality performance
Qualifications
- Bachelor's degree in Chemistry, Microbiology, or related scientific discipline (advanced degree a plus)
- 15+ years of experience in regulated manufacturing environments (OTC, pharmaceutical, medical device, or adjacent)
- Prior site‑level QA leadership with clear decision‑making authority
- Demonstrated experience owning FDA inspections and remediation efforts
- Strong understanding of microbiology programs, including water systems and EM
- Proven ability to delegate, build systems, and lead teams through change
- Comfortable operating on‑site in Elgin, IL (5 days/week)
Additional Details
- Base salary: ~$210K
- Relocation support available for the right candidate
- Lean, fast‑moving manufacturing environment with high visibility and impact
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