Head of Quality

Location:

New Richmond, WI (Onsite)

Employment Type:

Full-Time, Exempt
Compensation: $150,000 - $185,000 annually + annual bonus opportunity

Seeking an experienced and hands-on Head of Quality to lead all Quality Assurance and Quality Control functions at a New Richmond, Wisconsin manufacturing facility. This role serves as the senior quality leader for the site and is responsible for establishing, maintaining, and continuously improving the Quality Management System (QMS) while ensuring compliance with FDA, USDA, cGMP, GLP, GDP, GTP, ISO, and other applicable regulatory requirements.

The position provides strategic leadership, regulatory oversight, and operational direction to ensure product quality, compliance, inspection readiness, and continuous improvement across the organization. The Head of Quality leads both the Quality Assurance and Quality Control teams and reports directly to the CEO.

Direct Reports:

• Quality Assurance Manager
• Quality Control Manager
• Additional Quality personnel as assigned

• Lead and oversee all site Quality Assurance and Quality Control activities.
• Own and maintain the site Quality Management System (QMS).
• Ensure compliance with FDA, USDA, cGMP, GLP, GDP, GTP, ISO, and other applicable regulations.
• Lead regulatory inspections, customer audits, and quality-related responses and remediation activities.
• Oversee deviation management, investigations, CAPA, change control, document control, training, supplier quality, and risk management programs.
• Review and approve quality documentation, investigations, validation activities, and product disposition decisions.
• Develop quality metrics, management review processes, and continuous improvement initiatives.
• Partner with Manufacturing, Facilities, Supply Chain, Regulatory Affairs, R&D, and Executive Leadership to drive quality and compliance objectives.
• Lead supplier qualification and vendor quality programs.
• Recruit, develop, mentor, and retain quality professionals.
• Promote a culture of quality, accountability, and operational excellence.

• Bachelor's degree in Biology, Chemistry, Microbiology, Biochemistry, Pharmaceutical Sciences, Engineering, or a related scientific field.

• Minimum 10 years of experience in Quality Assurance, Quality Control, or Quality Systems within a regulated pharmaceutical, biologics, biotechnology, cell therapy, medical device, or related industry.
• Minimum 7 years of progressive Quality leadership experience within pharmaceutical manufacturing.
• Demonstrated experience leading Quality Management Systems in FDA-regulated environments.
• Experience managing regulatory inspections, audits, investigations, CAPA programs, and product release activities.
• Proven experience building and leading high-performing quality teams.

• Expert knowledge of cGMP and quality systems.
• Strong experience with investigations, CAPA, risk management, auditing, and validation programs.
• Excellent leadership, communication, and cross-functional collaboration skills.
• Strong analytical and problem-solving capabilities.
• Proficiency with Microsoft 365 and electronic Quality Management Systems (eQMS).

• Master's degree in a scientific discipline, Quality, or Business Administration.
• ASQ Certified Quality Auditor (CQA), CMQ/OE, Six Sigma Green Belt, Black Belt, or similar certification.
• Experience in biologics, cell therapy, tissue products, xenotransplantation, or combination products.
• Prior experience in a startup, growth-stage, or rapidly expanding manufacturing environment.
• Experience serving as a primary contact during FDA inspections.