Head of Quality Assurance

Staffing Network LLC; New Richmond (WI); On-site; USD 150,000 - 185,000; Full time

Job summary

Staffing Network LLC in New Richmond, Wisconsin seeks an experienced Head of Quality to lead all QA and QC functions at our manufacturing site. You will establish, maintain, and continuously improve the QMS while ensuring compliance with FDA, USDA, cGMP, GLP, GDP, ISO, and other regulatory requirements.

As senior quality leader, you will drive regulatory inspections, audits, CAPA and investigations, and mentor a growing team.

Qualifications

• Must have a Bachelor's degree in a relevant scientific field.
• Minimum 10 years in QA/QC or Quality Systems within regulated industries.
• 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.

Responsibilities

• 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.

Skills

Quality Assurance

Quality Control

QMS

CAPA

Auditing

Regulatory Compliance

Leadership

Cross-functional Collaboration

Education

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

Tools

eQMS

Microsoft 365

Job description

Compensation:

$150,000 - $185,000 annually + annual bonus opportunity

Position Summary

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.

Reporting Structure

Direct Reports:

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

Key Responsibilities

• 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.

Required Qualifications

Education

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

Experience

• 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.

Knowledge & Skills

• 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).

Preferred Qualifications

• 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.

This position is based onsite in New Richmond, Wisconsin and supports office, laboratory, manufacturing, cleanroom, and animal facility operations. Candidates must be able to comply with all biosecurity, biosafety, and PPE requirements, including strict animal‑contact withdrawal requirements.