- Merck & Co. (Rahway, NJ)
- …Internal Revenue Service (IRS) and various internal teams at our Company to ensure compliance and effective audit execution.The Federal Tax Audit Associate ... focusing on payment and interest calculations to ensure accuracy and compliance .Contribute to strategic audit planning by assessing reserve implications… more
- Merck & Co. (Rahway, NJ)
- …Auditor (CIA), Certified Management Accountant (CMA), Certified Fraud Examiner (CFE).Experience with Sarbanes-Oxley compliance .Big 4 Audit experience.Requisition ... continue advancing medical innovation and help improve lives.Our Company's Corporate Audit and Assurance Services' (MCAAS) primary purpose is to provide value-added… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …audits, remediations implemented and CAPAs pending.Support Risk Mitigation programs to ensure compliance to regulatory guidelinesEnsure up to date audit CAPA ... The Manager, Internal Process Audits is responsible for end-to-end GxP relevant audit activities that encompasses the internal systems and processes of the Daiichi… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance , GCP/Document Audits supports end-to-end audit activities per audit ... and its partners as applicable ensuring the execution of a risk-based audit program and effective CAPA management resulting from audits, health authority inspections… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of the value chain and customer focus. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to ... Develops comprehensive, relevant resources (eg training program, FAQs) to enable compliance with QMS process requirements across NNI and global as applicable… more
- BioAgilytix (Durham, NC)
- …the last mile: turning those clean, validated data streams into the audit -ready files our pharmaceutical sponsors need on tight deadlines. You'll harmonize results ... with hands-on responsibility for data quality, access control, and compliance protocols.Define standards, build quality assurance processes, and monitor data… more
- Insmed Incorporated (San Diego, CA)
- …Quality Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality lead on the gene therapy clinical ... regulatory agency inspections and vendor audits.Ability to ensure that a strategic audit plan is developed, designed and implemented, and that the activities are… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure comprehensive auditing of Business Partners as required to assure compliance with PV agreements.Participate in audit and inspection readiness ... and aggregate reporting for DSI products, both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety and periodic… more
- Repligen (Waltham, MA)
- …growing Supplier Quality team. You will a key role in ensuring the quality, compliance , and performance of Repligen's global supplier base. This is an opportunity to ... Notifications (SCNs)Evaluate and manage Supplier Change Notifications to ensure compliance with internal and regulatory quality standards.Coordinate cross-functional teams… more
- Merck & Co. (Durham, NC)
- …of process control, data collection techniques, and troubleshooting in compliance with SDLC, GMP, safety, and environmental regulations.- Actively support, ... approve automation documents, preventive maintenance, and SOPs to ensure compliance with Good Manufacturing Practices and safety.Participates in investigations of… more
- Twist BioScience (South San Francisco, CA)
- …technical excellence, robust software development practices, and regulatory compliance .Software Development & Implementation: Oversee the full Software Development ... advanced data utilization. Ensure robust system performance, availability, and audit readiness through proactive monitoring and maintenance.Cross-Functional Collaboration: Partner… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …shipping validation, and data integrity.Key Responsibilities Provide quality and compliance oversight for computer systems validation, process validation, equipment, ... reports).Review and approve periodic review documentation for qualified equipment/systems ( audit trails, user groups, system administration)Provide expertise and solutions… more
- Repligen (Waltham, MA)
- …Chromatography & Proteins.ResponsibilitiesThe Director, Quality will be responsible for:Maintaining site compliance to ISO 9001 for all aspects of the QMS including ... operational excellence initiatives in Quality Assurance.Maintain internal and external audit schedules; serve as host for site auditsMaintain risk-based strategy… more
- Repligen (Waltham, MA)
- …a key role in the monthly and quarterly close processes and ensures compliance with US GAAP and internal control requirements (SOX). This position supports general ... 10-K)Maintain documentation to support SOX internal control complianceParticipate in audit requests from internal and external auditorsSupport accruals, prepaids,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …on a consistent basis and identifying areas of potential non- compliance or operational risks.Responsibilities:Maintain regulatory procedural documentation, in line ... with GRA stakeholders to define appropriate KPIs/metrics to track process compliance , performance and adherenceWork with the data/systems SMEs to define reporting… 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 ... responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures… more
- …related field Requirements Compliance reporting, Data reporting, Federal Grant, Tutoring, Compliance Audit Robert Half is the world's first and largest ... Description Global Internal Audit & Compliance Manager to lead our client's global internal audit and compliance function, ensuring full alignment with… more
- UPMC (Pittsburgh, PA)
- **Join UPMC Corporate Finance as the Manager of IT Audit & Compliance !** Are you a seasoned IT audit professional with a passion for ensuring high-quality ... **UPMC Corporate Finance** is seeking a dynamic and experienced **Manager of IT Audit & Compliance ** to lead our audit team and make a significant impact… more
- Robert Half Finance & Accounting (Wayne, PA)
- Description Global, services provider seeks a detail oriented, Audit & Compliance Manager with proven expertise overseeing internal controls, corporate ... using technical accounting while performing risk management. Duties for this Audit & Compliance Manager are but not limited to developing risk assessments,… more
- AbbVie (North Chicago, IL)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Principal Auditor, Audit & Compliance provides leadership, direction and performs ... comprehensive audits for compliance with US and foreign regulation requirements, providing constructive...AbbVie specifications. + Provides feedback in the form of audit observations and reviews corrective actions to determine if… more
