Quality Risk Specialist IV

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.

• 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 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, escalates concerns appropriately, and implements 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.

• 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,…