Quality Risk Specialist IV; Hybrid

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…