Senior Quality Risk & Compliance Specialist (GxP)

Partner Therapeutics; Lynnwood (WA); Hybrid; USD 110,000 - 137,000; Full time

Benefits offered by this job

Discretionary annual bonus

Tuition assistance

Hybrid/Remote work program

Transit benefits (Seattle area)

Job summary

Partner Therapeutics in the United States (Lynnwood/Seattle area) seeks a Quality Risk Specialist IV to lead risk management, data integrity, and regulatory readiness across cGMP operations. You will identify, assess, document, and monitor quality risks with cross-functional teams to implement controls and improvements.

The role supports GxP manufacturing and testing, drives risk-based decision making, and ensures documentation and compliance evolving with FDA/EMA guidance.

Qualifications

• 6+ years of experience in a GxP manufacturing, testing, quality, or regulated environment.
• Experience conducting formal risk assessments using structured tools.
• Strong written and oral communication of risk assessments and mitigations.
• Able to translate technical information into clear risk conclusions and actions.

Responsibilities

• Serves as SME for Quality Risk Management and Data Integrity.
• Facilitates cross-functional teams in applying QRM principles across GxP operations.
• Supports GxP change controls including pre-change planning and Change Review Board representation.
• Leads formal risk assessments using FMEA, design FMEA, and other QRM methodologies.
• Authors and routes Risk Assessment Reports with clear rationales and mitigations.
• Maintains living risk library with periodic reviews and updates.
• Presents QRM metrics and risks during Quality Management Review.

Job description

Partner Therapeutics in the United States (Lynnwood/Seattle area) seeks a Quality Risk Specialist IV to lead risk management, data integrity, and regulatory readiness across cGMP operations. You will identify, assess, document, and monitor quality risks with cross-functional teams to implement controls and improvements.

The role supports GxP manufacturing and testing, drives risk-based decision making, and ensures documentation and compliance evolving with FDA/EMA guidance.