Maintains the cross functional risk management program for the site. To include Quality, EH&S, Operations, and strategic risk management initiatives - Accountable for implementation of the Quality, EH&S, and Operations risk management programs. Facilitates the risk management governance team – providing risk activity review, prioritization, and risk program support, Supports the development of the site risk management plan (forward looking risk initiatives). Works with the Risk Owner(s) to determine if a strategic risk assessment is necessary, e.g. FRA, Efficient Frontier Analysis, etc. Support the development and execution of the risk management communication plan . Builds organizational structure, technical expertise, and integration with other site processes to insure success, continuous improvement, and longevity of the RM program at the site.
|Requisitos - Requirements
Bachelor’s degree and 5 years of experience in FDA regulated manufacturing environment. Background: Life Sciences, Engineering or Computer Sciences. o Risk management expertise/ knowledge
o Experience (3-5yrs. min) in risk assessment’s planning and facilitation.
o Must have knowledge in risk assessment tools like FMEA, PrHA, Root Cause analysis, Fault Tree Analysis and others. Facilitation and execution experience is a must.
o Experience in assessing risks for construction projects/ activities
o Operational risks’ knowledge
o Project Management knowledge/execution
o Communication skills
o Negotiation skills
o Knowledge in Business Impact Analysis is a differentiator
o Experience/participation in Table Top exercises