Head of Quality

Our client is seeking an experienced and hands-on Head of Quality to lead all Quality Assurance and Quality Control functions at our New Richmond, Wisconsin 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 Head of Quality will provide strategic leadership, regulatory oversight, and operational direction to ensure product quality, regulatory compliance, inspection readiness, and continuous improvement across the organization. This position leads both the Quality Assurance and Quality Control teams and serves as a key member of the leadership team. This position will report directly to the CEO.

• Head of Quality
• Employment Type:
  
  Full-Time, Exempt
• Compensation: $150,000 - $185,000 annually
• This position is eligible for an annual bonus opportunity.

Head of Quality to lead all Quality Assurance and Quality Control functions at the New Richmond, Wisconsin facility as the senior quality leader for the site.

• 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.

• Direct Reports:
• Quality Assurance Manager
• Quality Control Manager
• Additional Quality personnel as assigned

• Education:
  
  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.
• Must have pharmaceutical experience

• 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.

• Compensation: $150,000 - $185,000 annually.
• This position is eligible for an annual bonus opportunity.

Work Environment:
This position is based onsite in New Richmond, Wisconsin and routinely supports office, laboratory, manufacturing, cleanroom, and animal facility operations. Candidates must be able to comply with all biosecurity, biosafety, and PPE requirements.