CMDO QA Supervisor: Compliance, CDMO Projects & Audits

Germer International; Madison (WI); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading compliance solutions provider in Madison, Wisconsin, is looking for a CMDO QA Supervisor. The role includes overseeing quality systems to ensure the integrity of data generated throughout the product development process. Key responsibilities involve releasing materials, organizing documentation, and collaborating with regulatory affairs. Candidates should have a Bachelor's degree and at least 5 years of relevant experience in quality assurance, with strong knowledge of FDA compliance and continuous improvement practices.

Qualifications

• 5+ years in material release and product development.
• Experience with validation and quality agreements.
• Knowledge of cGMP and FDA compliance.

Responsibilities

• Release raw materials and products for the CDMO business.
• Organize documentation and procedures for compliance.
• Collaborate on regulatory dossier preparation.
• Track and coordinate customer inquiries related to quality.
• Participate in audits and address findings.

Skills

Material release

Product development

Validation

Test method development

Quality agreements

Change controls

Continuous improvement

Education

Bachelor’s Degree

Job description

A leading compliance solutions provider in Madison, Wisconsin, is looking for a CMDO QA Supervisor. The role includes overseeing quality systems to ensure the integrity of data generated throughout the product development process. Key responsibilities involve releasing materials, organizing documentation, and collaborating with regulatory affairs. Candidates should have a Bachelor's degree and at least 5 years of relevant experience in quality assurance, with strong knowledge of FDA compliance and continuous improvement practices.