Key Responsibilities include the following:
• Support or lead, as appropriate, projects to identify information sources, develop data-driven risk analyses and develop decision-analytical frameworks in a complex quality environment.
• Develop and refine risk management tools and systems (including dashboards, actions plans, indicators, risk-frameworks, metrics, and surveillance reports) in collaboration with cross functional teams.
• Provide necessary support to the Quality Operations organization on risk management strategies and surveillance approaches utilizing data-driven decisions.
• Participate in the development of organizational risk management policies, procedures, and training to ensure ongoing support of excellence in quality.
• Establish and maintain best practices in areas of risk analytics, metrics, and statistical modeling.
• Work collaboratively with global teams to achieve organizational goals, projects will have significant and long-term impact on the strategy of Quality Operations
• Participate or lead, as appropriate, in the development and management of risk prevention and mitigation strategies.
• Responsible for product performance monitoring and reporting, which includes providing weekly and monthly risk analytics and metrics updates.
• Evaluate current processes and identify areas of risk/vulnerability and opportunities for improvement.
• Minimal Travel Required

Qualifications
Prerequisites:
• Minimum of a Bachelor’s degree in a scientific related discipline: Biology, Mathematics, Risk Management or Engineering. Additional training in either field would be considered a significant advantage.
• Proven experience supporting or leading quality risk management or analytics projects is required
• Minimum of 8 years of experience with risk management/analytics approaches. Advanced degree may be substituted for years of experience. Analytics experience within Pharmaceutical, Biotech or Medical device industry would be considered a plus.

Skills/Knowledge Required
Risk Management, Analytics, and Quality
• Must possess strong knowledge of Good Manufacturing Practices (GMP) regulations and guidances (ICH, CFR, PIC/S, etc.) as related to Pharmaceutical and Biotech Manufacturing
• Broad knowledge and experience in risk management tools and techniques (including, but not limited to: FMEA, FMECA, FTA, PRA)
• Practical knowledge of process analysis, standardization, continuous improvement, Lean, Six Sigma, and operational excellence
• Proficient in use of statistical software; solid and demonstrated understanding of basic to advanced statistical approaches
• Strong analytical and problem solving skills

Communication
• Must possess strong verbal and communication skills, and a well–developed ability to constructively work across functional areas and levels to achieve results.
• Expertise in project management principles and application including the ability to manage multiple projects simultaneously; Ability to multi-task a large number of projects and evaluate priorities with minimal supervision.
• Proficient in Microsoft Office Tools: Excel, Access, Word, PowerPoint, and Visio
• Practical knowledge of database systems and reporting (preferable, but not limited to: Oracle, SQL Server, Business Objects)
• Proficiency in developing presentations to facilitate meaningful discussions, with clearly communicated analysis, findings, and impact
• Must demonstrate the ability to grow and perform in areas of broader responsibility
• Passion for excellence