Fraud Investigation Manager manages the operations of the fraud investigations department. Develops policies and procedures to prevent fraud activities and to recover any incurred losses. Being a Fraud Investigation Manager identifies the weakness of current control process and recommends enhancements. Collaborates investigation with appropriate business partners and local, state and federal authorities. Additionally, Fraud Investigation Manager requires a bachelor's degree. Typically reports to a head of a unit/department. The Fraud Investigation Manager typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. To be a Fraud Investigation Manager typically requires 3+ years of managerial experience. (Copyright 2024 Salary.com)
Legend Biotech is seeking Investigations Excellence Lead as part of the Quality team based in Raritan, NJ.
Role Overview
The Investigations Excellence Lead manages the Quality Investigations program in support of cell therapy manufacturing, in full compliance with established cGMP requirements. Functions and activities include managing and leading activities focusing on Investigations and CAPAs, such as improvement projects and Kaizens, training qualification, coaching, and maintaining/reporting metrics and data. The role will be responsible for formal escalation of critical investigations and will develop and implement long-term strategies and continuous improvements for the Investigations program.
Key Responsibilities
A minimum of a Bachelor’s Degree in Science, Information Science or equivalent technical discipline is required.
A minimum of 14 years relevant work experience is required. It is preferable that the candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.
Strong interpersonal and written/oral communication skills.
Proven people management and leadership experience is required.
Experience working with quality systems is required.
Extensive knowledge of chemical, biochemical and microbiological concepts is required.
Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is preferred.
Ability to quickly process complex information and often make critical decisions with limited information.
Ability to handle multiple priorities on a daily basis while being flexible and responsive to frequently shifting priorities.
Proficient in applying process excellence tools and methodologies.
The candidate must be highly organized and capable of working in a team environment with a positive attitude.
Good written and verbal communication skills are required.
Ability to summarize and present results, and experience with team-based collaborations is a requirement.
Experience developing and setting long-term objectives.
Ability to identify/remediate gaps in processes or systems
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