Quality Risk Specialist IV

Partner Therapeutics

Quality Risk & Compliance Specialist managing Quality Risk Management, Data Integrity, and Audit Readiness at Partner Therapeutics. Ensuring compliance through risk assessments, training, and program metrics.

Posted 5/9/2026full-timeLynnwood • Washington • 🇺🇸 United StatesMid-LevelSenior💰 $110,000 - $137,000 per yearWebsite

About the role

Key responsibilities & impact

Serves as a subject matter expert (SME) for Quality Risk Management and Data Integrity programs.
Facilitates cross-functional teams in the application of Quality Risk Management and Data Integrity principles.
Supports GxP change controls.
Leads formal risk assessments using recognized risk tools.
Authors, reviews, and routes Risk Assessment Reports in MasterControl.
Evaluates residual risk following implementation of mitigation activities.
Coaches SMEs and cross-functional Partners on effective mitigation strategies.
Develops and delivers training on Quality Risk Management tools and methodologies.
Manages multiple risk-related projects independently.

Requirements

What you’ll need

High school diploma or GED
6+ years of experience in a GxP manufacturing, testing, quality, or regulated operational environment
Hands-on experience facilitating formal risk assessments with cross-functional teams
Strong working knowledge of Quality Risk Management principles, tools, and application in a regulated GxP environment.
Experience applying risk tools such as FMEA, risk ranking and filtering, hazard analysis, or other structured risk assessment methodologies.
Solid understanding of FDA, EMA, ICH, USP, and cGMP expectations related to Quality Risk Management, Data Integrity, and pharmaceutical quality systems.
Strong critical thinking, analytical, and problem-solving skills.
Proficiency with MS Office products, especially Word and Excel essential;

Benefits

Comp & perks

Health insurance
401(k) matching program
Discretionary cash bonus
Tuition and continuing education assistance
Casual Hybrid or Remote workplace program

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Quality Risk ManagementData Integrityrisk assessmentsFMEArisk rankinghazard analysiscGMPpharmaceutical quality systemsanalytical skillsproblem-solving

Soft Skills

critical thinkingcoachingcommunicationfacilitationindependent project management