Director of Quality and Regulatory Affairs
EPM Scientific, Elgin, IL, United States
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
#J-18808-Ljbffr
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
#J-18808-Ljbffr