Senior Quality Systems Lead - cGMP & Compliance

Scientific Protein Laboratories LLC; Waunakee (WI); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Competitive compensation

Medical, Dental and Vision on Day 1

Life and AD&D Insurance

Short and Long-term Disability

401k

Paid Holidays

Career advancement

Team-oriented environment

Job summary

Scientific Protein Laboratories LLC in Waunakee, WI seeks a Quality Systems Manager to lead cGMP training, investigations (including customer complaints), deviations, change controls and CAPAs. Develops and maintains a cGMP-compliant Quality Management System and oversees release of intermediates and finished products.

The role also hosts audits, approves validation/qualification documents, coordinates training, and drives continuous improvement to satisfy FDA/ICH, USDA and ISPE standards while

Qualifications

• 10+ years in quality systems or QA in pharma (15+ preferred).
• Experience with FDA/ICH, USDA and ISPE standards.
• Proven ability to manage documentation and audits.

Responsibilities

• Oversee cGMP training, investigations, deviations, CAPAs and validation/qualification documents.
• Coordinate procedures and maintain the Quality Management System.
• Compile metrics and manage release of intermediates and finished products.
• Host external audits and customer inspections; ensure timely responses.

Skills

Quality systems management

cGMP training

Investigations & CAPAs

Audit coordination

Education

Associate's or Bachelor's degree or above

Tools

eQMS

Job description

Scientific Protein Laboratories LLC in Waunakee, WI seeks a Quality Systems Manager to lead cGMP training, investigations (including customer complaints), deviations, change controls and CAPAs. Develops and maintains a cGMP-compliant Quality Management System and oversees release of intermediates and finished products.

The role also hosts audits, approves validation/qualification documents, coordinates training, and drives continuous improvement to satisfy FDA/ICH, USDA and ISPE standards while