Senior Principal Quality Scientist - R&D Compliance Leader

Real Staffing; Saint Paul (MN); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Real Staffing is seeking a Senior Principal Quality Scientist in the Twin Cities area (Hybrid) to lead quality strategies across lab, drug product, and medical device development. The role partners with R&D and Quality leadership to ensure global compliance and robust quality management in a regulated environment.

The successful candidate will review and approve critical documentation, drive CAPA and investigations, and support regulatory inspections with a collaborative, continuous improvement

Qualifications

• Bachelor's degree in Engineering, Science, Quality, or related field.
• 6+ years in medical device, pharmaceutical, biotechnology, or other regulated industry.
• 5+ years supporting analytical chemistry, microbiology, or regulated labs.
• Strong knowledge of QMS, GLP, GMP, and quality engineering principles.
• Ability to influence stakeholders and work independently.

Responsibilities

• Serve as the primary Quality SME for lab, drug product, and medical device development activities.
• Partner with R&D and Quality leadership to establish site-level quality procedures and compliance processes.
• Review and approve quality documentation including validation protocols/reports, qualification documents, training plans, change controls, investigations, and CAPA records.
• Support audits by developing plans, participating in execution, and representing Quality during inspections.
• Lead and support quality system processes and cross-site harmonization.

Skills

Quality leadership

QMS/GMP/GLP

Regulatory inspections

Auditing

CAPA

Cross-functional collaboration

Documentation reviews

Education

Bachelor's degree in Engineering or Science

Job description

Real Staffing is seeking a Senior Principal Quality Scientist in the Twin Cities area (Hybrid) to lead quality strategies across lab, drug product, and medical device development. The role partners with R&D and Quality leadership to ensure global compliance and robust quality management in a regulated environment.

The successful candidate will review and approve critical documentation, drive CAPA and investigations, and support regulatory inspections with a collaborative, continuous improvement