Quality Risk Specialist IV; Hybrid Job Lynnwood area,Washington USA,Quality Assurance

Position: Quality Risk Specialist IV (Hybrid)
POSITION SUMMARY

The Quality Risk & Compliance function establishes and maintains best practices for Quality Risk Management, Data Integrity, and Audit Readiness to support patient safety, product quality, and cGMP compliance Quality Risk & Compliance Specialist is responsible for identifying, assessing, documenting, and monitoring quality risks associated with cGMP manufacturing, testing, and supporting GxP operations.

PRIMARY RESPONSIBILITIES

Serves as a subject matter expert (SME) for Quality Risk Management and Data Integrity programs, providing guidance to cross-functional teams and site stakeholders.
Facilitates cross-functional teams in the application of Quality Risk Management and Data Integrity principles across GxP manufacturing, testing, and support operations.
Supports GxP change controls by:
- Participating in pre-change planning meetings
- Representing Quality Risk at Change Review Board meetings
- Assessing the impact of proposed changes on existing risk assessments and the living risk library
- Determining when a change requires a formal risk assessment
- Ensuring applicable risk assessments are updated, routed, and approved in alignment with internal procedures.
Leads formal risk assessments using recognized risk tools, including process FMEA, design FMEA, and other appropriate Quality Risk Management methodologies.
Guides subject matter experts in identifying appropriate risk controls, mitigation strategies, and preventive actions.
Authors, reviews, and routes Risk Assessment Reports in Master Control, ensuring conclusions, rationales, mitigations, and residual risk determinations are clearly documented.
Evaluates residual risk following implementation of mitigation activities and determine whether risks have been reduced to an acceptable level.
Maintains the living risk library through periodic review, annual updates, and incorporation of new or revised risk information.
Coaches SMEs and cross-functional Partners on effective mitigation strategies, risk ranking, and risk-based decision-making.
Develops and delivers training on Quality Risk Management tools and methodologies, including process and design FMEAs.
Manages multiple risk-related projects independently, ensuring strong organization, prioritization, follow-through, and timely completion.
Monitors and interprets FDA, EMA, ICH, and other regulatory expectations related to Quality Risk Management, Data Integrity, and impurity risk controls, including but not limited to:
- ICH Q9(R1), Quality Risk Management
- ICH Q3D(R2), Elemental Impurities
- ICH Q3E, Assessment and Control of Extractables and Leachables
- FDA Guidance:
  Control of Nitrosamine Impurities in Human Drugs
- FDA Guidance:
  Data Integrity and Compliance with Drug cGMP
Presents Quality Risk Management program metrics, trends, and key risks during Quality Management Review.
Manages significant risks and mitigation activities through the Quality Risk Register and the Quality Risk Council or other appropriate governance forums.
Administers Advanced Risk Assessment software used to document, analyze, and maintain risk assessments.
Drives issue resolution, escalate concerns appropriately, and implement preventive improvements that strengthen the Quality Risk Management program.
Applies industry best practices through continuous learning, benchmarking, and external networking.
Participates in cross-functional projects that support business needs, compliance improvement, and professional development.
Complies with all internal SOPs, cGMP requirements, safety procedures, and applicable regulatory standards.
Completes all required Quality and Compliance training within assigned timelines.

KNOWLEDGE, SKILLS, ABILITIES

Required:

Strong working knowledge of Quality Risk Management principles, tools, and application in a regulated GxP environment.
Hands-on experience facilitating formal risk assessments with cross-functional teams.
Experience applying risk tools such as FMEA, risk ranking and filtering, hazard analysis, or other structured risk assessment methodologies.
Ability to translate complex technical, manufacturing, testing, and quality information into clear risk assessments, reports, conclusions, and mitigation plans.
Strong risk assessment writing skills, including clear documentation of assumptions, rationale, conclusions, mitigations, and/or residual risk when writing risk assessment reports, quality procedures, and supporting documentation for a regulated industry.
Solid understanding of FDA, EMA, ICH, USP, and cGMP expectations related to Quality Risk Management, Data Integrity, and pharmaceutical quality systems.
Experience supporting or interacting with regulatory inspections, audits, or inspection-readiness activities.
Strong critical thinking, analytical, and problem-solving skills with the proven ability to formulate solutions to propel the organization forward.
Resourceful with proven ability to lead, manage, and leverage an extensive internal network of stakeholders, team members, and external resources to plan and…