Senior QA Supervisor – CDMO Product Development & Compliance

Germer International - Pharmaceutical Recruiting; Madison (WI); On-site; USD 110,000 - 150,000; Full time

Job summary

Germer International - Pharmaceutical Recruiting is seeking a CMDO QA Supervisor to develop, implement, and maintain the Quality System ensuring data integrity for process development, engineering batches, and clinical trials. The role focuses on regulatory compliance and customer inquiries across CDMO projects, with 100% onsite work.

Responsibilities include release of materials and products, procedure maintenance, regulatory dossier support, and audits.

Qualifications

• Bachelor's degree required.
• 5+ years in material release, product development and validation.
• Experience with test method development/validation.
• Experience with investigations approvals, quality agreements, and change controls.
• Preferred: biologics, drug substances, DMFs.

Responsibilities

• Release raw materials, products (development batches, engineering batches, clinical trial batches) and GLP test activities.
• Organize establishment/maintenance of relevant procedures/documents.
• Collaborate with customers and Regulatory Affairs to prepare regulatory dossiers.
• Provide direction on applying quality requirements to CDMO projects.
• Draft and verify CDMO Quality Agreements and ensure compliance (including customer notifications).
• Track and coordinate responses to all customer communications/inquiries.
• Continuous improvement of cGMP Quality Systems for CDMO projects per FDA/ICH/USDA/ISPE.
• Compile and communicate metrics for CDMO projects to management.
• Participate in audits and address audit findings as needed.
• Review/approve CDMO product release and shipping documentation.

Skills

Material release

Product development

Test method validation

Quality agreements

Change controls

Education

Bachelor's Degree

Job description

Germer International - Pharmaceutical Recruiting is seeking a CMDO QA Supervisor to develop, implement, and maintain the Quality System ensuring data integrity for process development, engineering batches, and clinical trials. The role focuses on regulatory compliance and customer inquiries across CDMO projects, with 100% onsite work.

Responsibilities include release of materials and products, procedure maintenance, regulatory dossier support, and audits.