- Daiichi Sankyo, Inc. (Bernards, NJ)
- …activities required to resolve process deviations / CAPAs arising from either internal audit or HA inspection findingsWork with cross-functional stakeholders to ... other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory… more
- Insmed Incorporated (San Diego, CA)
- …and reports written according to SOPs and regulations.Oversee GCP activities (including internal or external audit observations and development of adverse ... managing regulatory agency inspection and working with regulators and internal staff to help prepare for inspections is required.Experience developing SOPs,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …NN Standard Operating Procedures (SOPs) Advanced knowledge and participation on internal audit /inspection readiness (ie FDA PADE inspection) Excellent ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...NNI processes to mitigate non-compliance and deviation occurrence Support internal and external stakeholders with issue resolutions in a… more
- Twist BioScience (South San Francisco, CA)
- …culture of continuous improvement, technical excellence, robust software development practices , and regulatory compliance.Software Development & Implementation: ... of all manufacturing data within the MES, critical for regulatory submissions and audit trails. Develop and...with cloud platforms (eg, AWS, Azure, GCP) and DevOps practices .Direct experience participating in regulatory audits (eg,… more
- Repligen (Waltham, MA)
- …the Senior Management team.Facilitate operational excellence initiatives in Quality Assurance.Maintain internal and external audit schedules; serve as host for ... including deviation support, root cause analysis, customer complaint management, hosting customer/ regulatory audits and Certificate of Quality generation at an ISO… more
- Eisai, Inc (Nutley, NJ)
- …of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This ... role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of...audits of study sites, clinical vendors, clinical documents, and internal process audits Facilitate Sponsor health authority inspections of… more
- Citigroup (Tampa, FL)
- …execute and deliver audit reports in a timely manner, in accordance with Internal Audit and Regulatory standards + Review and approve the Business ... This role will cover the Data, Regulatory and Account Operations teams. Data Operations provide...for broader corporate issues + Apply in-depth understanding of Internal Audit standards, policies and regulations to… more
- SMBC (Phoenix, AZ)
- …to drive impactful insights to the business. + Demonstrates strong understanding of internal audit techniques, regulatory requirements, internal ... the Team Lead who in turn reports to the Internal Audit Department (IAD) Chief Audit... experience in areas related to Business and Risk Audit with a financial institution, regulatory agency,… more
- SMBC (Los Angeles, CA)
- …to drive impactful insights to the business. + Demonstrates strong understanding of internal audit techniques, regulatory requirements, internal ... the Team Lead who in turn reports to the Internal Audit Department (IAD) Chief Audit... experience in areas related to Business and Risk Audit with a financial institution, regulatory agency,… more
- Citigroup (Irving, TX)
- …execute and deliver audit reports in a timely manner, in accordance with Internal Audit and Regulatory standards + Review and approve the Business ... + **Short term and Long term Financial Forecasting for Regulatory and Internal Management Reporting** + **Capital...for broader corporate issues + Apply in-depth understanding of Internal Audit standards, policies and regulations to… more
- Citigroup (Tampa, FL)
- …execute and deliver audit reports in a timely manner, in accordance with Internal Audit and Regulatory standards + Review and approve the Business ... Manager is responsible for leading, planning and execution, and oversight of Internal Audit assurance activities (audits; issue remediation testing), primarily… more
- Citigroup (Tampa, FL)
- …build effective teams and manage a budget + Deliver audit reports, Internal Audit and Regulatory issue validation and business monitoring and ... senior level management position responsible for managing a complex and critical unit within Internal Audit , in coordination with the Audit team. The overall… more
- American Express (Phoenix, AZ)
- …accordance with American Express' Internal Audit Methodology, internal policies and standards, and regulatory expectations, while consistently delivering ... a Professional Practices group responsible for managing audit operations, quality, and standards; regulatory relations;...of control theory and professional internal auditing practices throughout the internal audit … more
- Citigroup (Irving, TX)
- …+ Consistently develop, execute and deliver audits in a timely manner, in accordance with Internal Audit and Regulatory standards. + Review and approve the ... automate the governance reporting process using established data management practices and using a variety of BI tools and...extractions and segmentations for completeness, accuracy and applicability to internal audit testing and regulatory … more
- M&T Bank (Buffalo, NY)
- …Drive audit teams in the planning and execution of validation procedures for Internal Audit and Regulatory issues that require subject matter expertise. ... Audit Plan Completion** + Stay abreast of best practices , industry developments, and changing or emerging risks and...and critical thinking. + Specific subject matter expertise regarding internal audit disciplines or in one or… more
- M&T Bank (Buffalo, NY)
- …Drive audit teams in the planning and execution of validation procedures for Internal Audit and Regulatory issues that require subject matter expertise. ... Audit Plan Completion + Stay abreast of best practices , industry developments, and changing or emerging risks and...and critical thinking. + Specific subject matter expertise regarding internal audit disciplines or in one or… more
- M&T Bank (Buffalo, NY)
- …Drive audit teams in the planning and execution of validation procedures for Internal Audit and Regulatory issues that require subject matter expertise. ... Audit Plan Completion + Stay abreast of best practices , industry developments, and changing or emerging risks and...initiative and critical thinking. Specific subject matter expertise regarding internal audit disciplines or in one or… more
- Bank OZK (Tampa, FL)
- …policies and procedures. + Delivers on time high quality audit reports, Internal Audit and Regulatory issue validation and (where appropriate, branch ... Audit Plan, by reviewable entity, for assigned businesses in accordance with Internal Audit standards, relevant government statutes and regulations and Bank… more
- M&T Bank (Clanton, AL)
- …Drive audit teams in the planning and execution of validation procedures for Internal Audit and Regulatory issues that require subject matter expertise. ... Responsibilities:** Successful Audit Plan Completion + Stay abreast of best practices , industry developments, and changing or emerging risks and consult with the… more
- Citigroup (Irving, TX)
- …Oracle, SQL Server, and other databases for completeness, accuracy and applicability to internal audit testing and regulatory requirements. + Consistently ... reports in a timely manner, in accordance with Internal Audit and Regulatory standards...sound ethical judgment regarding personal behavior, conduct and business practices , and escalating, managing and reporting control issues with… more
