Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Position Summary

The Director of Quality Risk Management will establish global standards and processes for managing risks, in line with industry expectations and regulations. They will also improve the existing Quality Risk Register program to ensure effective risk prioritization.

The main responsibility of this role is to lead and support cross-functional activities and teams in maintaining, controlling, and improving QRM processes within their designated area. They will also be responsible for gathering, analyzing, visualizing, and presenting risk information and metrics.

Responsibilities

• Strong contributor to the design and development of the strategy for the global deployment of the Quality Risk Management program including governance, communication, infrastructure requirements, deployment timeline, tool application, monitoring, and metrics.
• Develop risk methodologies and customized risk tools for quality management system and business needs, such as risk profiles and facility design.
• Develop and implement a training strategy and materials for risk management, including tools like Failure Mode and Effect Analysis (FMEA), Preliminary Hazards Analysis (PHA), Hazard Analysis and Critical Control Points (HACCP), and other tailored risk tools.
• Maintain standards in support of current regulatory requirements (ISO, ICH) and industry expectations for Quality Risk Management.
• Take charge of risk reviews and mitigations, analyze and interpret data from various sources, and report trends to improve site and business performance.
• Lead the global Risk Community of Practice (Risk Champions) to share knowledge and standard methodologies.
• Support the development and generation of performance indicators to measure the progress of implementation and effectiveness use of the QRM.
• Apply data-driven approaches to identify trends, root causes, and areas for improvement.
• Maintain comprehensive documentation of risk management activities, including risk assessments, mitigation plans, and monitoring reports.
• Prepare and present regular reports on risk management activities and outcomes to senior management.
• Ensure that risk management documentation is accurate, complete, and readily accessible for audits and inspections.
• Manage and facilitate the Global Risk Register.
• Support sites through audits and inspections including audit preparation activities, addressing questions and requests specific to the Risk Management Program.
• Support sites with root cause analysis (RCA), Corrective Action Preventive Actions (CAPAs), and Effectiveness Checks development, where associated with risks.
• Coach and train business teams on the Risk Management Program.
• Directly responsible for the supervision, management, and development of direct reports, ensuring optimal allocation of resources for coverage of work and objectives.
• Perform other work-related duties as assigned.

• Bachelor's degree in Engineering or a related field, subject area, or team, or equivalent experience.
• 10+ years of quality assurance and/or business process experience in the medical device, biotech, and/or pharmaceutical industry.
• Quality Risk Management and/or medical device risk management experience.
• Strong understanding and practical use of ICH, ISO, and cGMP regulations.
• Recent experience showcasing the ability to plan, work together, and successfully complete process improvements on a global scale.
• Strong collaboration and conflict management skills when working transversally across multiple business units to achieve global objectives.
• High level of energy and enthusiasm and ability to energize others.
• Proven critical thinking skills to be able to connect GxP requirements with business processes.
• Effective verbal and written communication skills, including presentation skills. Able to communicate effectively at all levels of a matrix organization, as well as teach and present new ideas with clarity and simplicity.
• Ability to influence policies/positions in response to a changing regulatory landscape. Experience with the use of risk management tools (FMEA, HACCP, process mapping, and root cause analysis tools).
• Knowledge of digital systems to manage data and reporting, experience using data to drive solutions to business challenges.
• A willingness to contribute within a learning environment by sharing knowledge and standard methodologies across the organization.

• The ideal candidate has a range of leadership experiences and skills, including the ability to collaborate, influence, coach, and guide colleagues to achieve meaningful results and make a business impact.
• Reliable, responsible self-starter who works well independently and demonstrates excellent decision-making abilities.
• Highly organized with a keen eye for detail, accuracy, and quality product.
• Above average organizational, interpersonal, and team-oriented skills with strong competence when interacting with internal and external customers.
• Ability to perform several tasks simultaneously to meet deadlines.
• Flexible, enthusiastic, highly adaptable, quick to assimilate new information, and demonstrates initiative as a team member and leader.
• Demonstrates understanding of the workflow process, roles, and responsibilities of multiple functional areas.
• Excellent written and verbal communication, presentation, and analytical skills.
• Ability to lead effective meetings, working sessions, and presentations to leadership.
• Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, Teams) and SharePoint and willingness to embrace new technologies.