Senior Quality Risk & Compliance Leader

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

Benefits offered by this job

Annual discretionary cash bonus

401(k) matching

Tuition assistance

Free ORCA pass

Job summary

Partner Therapeutics in Lynnwood is seeking a Quality Risk & Compliance Specialist to support patient safety, product quality, and cGMP compliance. This role involves leading risk assessments, providing guidance on Quality Risk Management, and ensuring regulatory compliance across GxP operations.

The ideal candidate will have extensive experience in risk management within a regulated environment, strong problem-solving skills, and a commitment to quality assurance. In addition to a competitive salary, benefits include a hybrid workplace program and professional development support.

Qualifications

• Over 6 years of experience in a GxP environment.
• Experience in formal risk assessments and regulatory compliance.
• Strong organizational skills for managing multiple projects.

Responsibilities

• Serve as SME for Quality Risk Management.
• Facilitate cross-functional risk assessments.
• Evaluate residual risks and maintain risk library.

Skills

Quality Risk Management principles

Hands-on risk assessment facilitation

FMEA and hazard analysis

Documentation skills

Critical thinking and problem-solving

MS Office proficiency

Education

High school diploma or GED

Bachelor's degree in Science or related field

Tools

Advanced Risk Assessment software

MasterControl

Job description

Partner Therapeutics in Lynnwood is seeking a Quality Risk & Compliance Specialist to support patient safety, product quality, and cGMP compliance. This role involves leading risk assessments, providing guidance on Quality Risk Management, and ensuring regulatory compliance across GxP operations.

The ideal candidate will have extensive experience in risk management within a regulated environment, strong problem-solving skills, and a commitment to quality assurance. In addition to a competitive salary, benefits include a hybrid workplace program and professional development support.