Quality Risk Specialist IV

About the role

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 at PTx. The 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
  • Absessing 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 MasterControl, 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.
• Marksers 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.

Knowledge, skills, abilities

• 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 resolve issues.
• Strong, collaborative relationship management and interpersonal skills required to quickly gain confidence of stakeholders and team members.
• Possesses strong organizational and prioritization skills to maintain a high level of productivity and priority-setting in order to complete assignments on-time and on-budget.
• Excellent soft skills including a bias towards action, the ability and willingness to give and receive constructive feedback, is comfortable working within a diverse team and across multiple functions, exhibits a consistently constructive attitude, and is adaptable and at ease with handling unexpected changes and challenges.
• Solid English language communication skills, both oral and written, are required for this highly collaborative role. Willingness and ability to clearly express opinions and ask questions. Comfortable actively participating in cross-functional meetings.
• Proficiency with MS Office products, especially Word and Excel essential; ability and willingness to quickly adopt other job-specific applications will be necessary.

Experience & Education

• Required: High school diploma or GED, 6+ years of experience in a GxP manufacturing, testing, quality, or regulated operational environment, 6+ years of progressively responsible GxP experience.
• Preferred: Experience leading cross-functional risk teams using multiple Quality Risk Management tools, experience developing and delivering training in person or virtually, experience with Advanced Risk Assessment software or other risk management platforms, familiarity with MasterControl, SharePoint, and Smartsheet software, project management training, certification, or practical project leadership experience, knowledge of Data Integrity expectations and practical controls within GxP systems and processes.