Head of QA & Regulatory Affairs for Global Compliance

Endsulin; Madison (WI); On-site; USD 120,000 - 150,000; Full time

Job summary

Endsulin, a cutting-edge pre-clinical gene therapy startup in Madison, WI, is seeking a Director of Quality Assurance & Regulatory Affairs. This role is vital for building and maintaining quality systems aligned with commercialization goals in global markets. The ideal candidate will lead efforts to ensure product quality and compliance across departments.

Applicants should have a Bachelor’s degree in a relevant field, over 10 years of QMS experience, and extensive regulatory inspection expertise. This position offers a dynamic environment where innovation is key, and providing quality products is of utmost importance.

Qualifications

• Bachelor’s degree required in a science, engineering field or related discipline.
• 10 years of QMS experience and demonstrated leadership experience.
• Proficiency with ISO 13485, Good Clinical Practices (GCP).

Responsibilities

• Develop, implement, and maintain quality and regulatory programs.
• Partner with R&D and Marketing for market access guidance.
• Oversee internal and external audits.

Skills

Regulatory inspection experience

Global registration understanding

Experience with computer software validation

Knowledge of ICH, cGMP, cGDP

Excellent communication skills

Education

Bachelor’s degree in a science or engineering field

MBA

Tools

QMS and ERP software

ISO 13485

Good Clinical Practices (GCP)

Job description

Endsulin, a cutting-edge pre-clinical gene therapy startup in Madison, WI, is seeking a Director of Quality Assurance & Regulatory Affairs. This role is vital for building and maintaining quality systems aligned with commercialization goals in global markets. The ideal candidate will lead efforts to ensure product quality and compliance across departments.

Applicants should have a Bachelor’s degree in a relevant field, over 10 years of QMS experience, and extensive regulatory inspection expertise. This position offers a dynamic environment where innovation is key, and providing quality products is of utmost importance.