Senior Quality Systems Engineer, GMP & Change Control

Sunrise Systems, Inc.; Salt Lake City (UT); On-site; USD 90,000 - 150,000; Full time

Job summary

Sunrise Systems, Inc. seeks a senior QA/Quality Systems professional to support the QMS, documentation management, and continuous improvement.

You will oversee change management, annual product review, and data trending while ensuring adherence to GMP standards across operations. The role requires to review and approve SOPs, risk assessments and quality records, with strong technical writing and cross-functional communication skills.

Qualifications

• Bachelor's Degree in a scientific discipline with strong QA background.
• 7+ years progressive pharmaceutical experience, including QA.
• Experience with Health Authority inspections is a plus.

Responsibilities

• Oversee change management, annual product review, and quality metrics.
• Review and approve SOPs, protocols, risk assessments and records.
• Maintain CGMP compliance and quality systems.
• Lead cross-functional collaboration across site teams.
• Provide documentation management and continuous improvement support.
• Support inspections and audits as needed.
• Train and mentor staff to meet quality standards.

Skills

Quality Systems

GMP Compliance

Change Control

Documentation Management

SOPs & Protocols Review

Risk Assessments

Quality Records

Independent Problem-Solving

Decision-Making

Technical Writing

Cross-Functional Communication

Senior-Level Experience

Quality Assurance Experience

Compliance Experience

Education

Bachelors in Life Sciences

Tools

Trackwise

Veeva

ERP systems

LMS

EDMS

Job description

Sunrise Systems, Inc. seeks a senior QA/Quality Systems professional to support the QMS, documentation management, and continuous improvement.

You will oversee change management, annual product review, and data trending while ensuring adherence to GMP standards across operations. The role requires to review and approve SOPs, risk assessments and quality records, with strong technical writing and cross-functional communication skills.