Director of Quality and 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.

• 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
  
  

• 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
  
  

• 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
  
  

• 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
  
  

• 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
  
  

• 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)
  
  

• Base salary: ~$210K
• Relocation support available for the right candidate
• Lean, fast‑moving manufacturing environment with high visibility and impact