Senior Quality Systems Manager – cGMP Compliance & Audits

Scientific Protein Laboratories LLC; Waunakee (WI); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical, Dental & Vision on Day 1

Life and AD&D Insurance

Short & Long-term Disability

Flexible Saving Account options

Job summary

Scientific Protein Laboratories LLC, located near Madison, WI in Waunakee, seeks a seasoned QA Supervisor to lead the site’s Quality Systems. The role manages cGMP training, investigations, deviations, CAPAs, and validation/qualification documents, while coordinating external audits and customer communications.

Responsibilities include producing Annual Product Review documentation, maintaining procedures, and coaching a cross-functional quality team to uphold regulatory compliance and product

Qualifications

• Experience building and maintaining cGMP-compliant Quality Management Systems.
• Ability to coach and develop quality systems teams to goals.
• Strong collaboration with internal functions and external authorities.

Responsibilities

• Manage Quality Systems functions including training, investigations, deviations, change controls, CAPAs and documentation.
• Oversee procedures/documents establishment and maintenance; communicate metrics to management.
• Prepare Annual Product Review documentation for all SPL marketed products; ensure timely completion.
• Draft and verify customer-related Quality Agreements and monitor compliance.
• Investigate process deviations, product failures, customer complaints or facility incidents; approve minor deviations and CAPAs.
• Participate in Material Review Board and address all customer communications.

Skills

Quality Systems

Coaching

Cross-functional leadership

cGMP knowledge

Investigation management

Education

Associate's Degree

Bachelor's Degree in natural sciences

Job description

Scientific Protein Laboratories LLC, located near Madison, WI in Waunakee, seeks a seasoned QA Supervisor to lead the site’s Quality Systems. The role manages cGMP training, investigations, deviations, CAPAs, and validation/qualification documents, while coordinating external audits and customer communications.

Responsibilities include producing Annual Product Review documentation, maintaining procedures, and coaching a cross-functional quality team to uphold regulatory compliance and product