- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The Manager, Internal Process Audits is responsible for end-to-end GxP relevant audit activities that encompasses the internal systems and processes of the ... appropriate for the area of GxP audits assigned.Responsibilities:Execute the audit program for internal systems as applicable...objectives and adjust the plan as needed to support business functions and internal stakeholders to execute… more
- Merck & Co. (Rahway, NJ)
- …and assessments across all our Company divisions and functions to evaluate the adequacy of internal controls and deliver audit reports that add value to the area ... and techniques to independently assess risk and evaluate the effectiveness of internal controls in business scenarios in accordance with timelines.Applies body… more
- Merck & Co. (Rahway, NJ)
- …Experience and Skills:A minimum of 3 years work experience in internal audit , public accounting, or general accounting.Experience with ... Accounting Firm Experience.Required Skills: Accounting, Accounting, Adaptability, Asset Accounting, Audit Internal Controls, Contract Audits, Data Analysis,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …related to Adverse Event reporting and quality tasks performed by suppliers and business partners to ensure compliance with SDEA requirements. Relationships This ... limited to the following: all units in Patient Safety, NAO QA, NNI Legal, NNI Compliance , NNI Commercial, NNI Finance, Global Business Services (GBS), PV & GDP… more
- Cipla (Hauppauge, NY)
- …focus on audit trail review, data integrity, and overall GxP compliance . Responsibilities: Perform detailed reviews of the equipment audit trails associated ... of the batch records (manufacturing and packaging) to ensure compliance with GMP, regulatory standards, and internal ...or other violations are detected. Provide necessary documentation and audit trail reports during internal and external… more
- Capital One (Baltimore, MD)
- …within Tech, Cyber, Product, second line risk organizations, the developer community, and Internal Audit on key technology risks and actions needed Develop and ... providing support for novel and developing technologies, as well as critical business strategies. Diverse perspectives and experiences are valued as we work to… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …and/or Solution architect to design and deliver technical solutions align with business requirements and stakeholder needs. Ensure audit preparedness and support ... If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to… more
- Tris Pharma (Monmouth Junction, NJ)
- …ensure timely and accurate delivery of financial information and support the company's business objectives. Ensures compliance with GAAP across all revenue and ... research and documentation; Drafts white papers and accounting memos to support audit and regulatory compliance Provides guidance on new accounting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal workflows and performance metrics to ensure departmental KPIs and regulatory compliance are consistently met Audit & Inspection Readiness Support the ... processing issues and provides support and escalation channels for both internal teams and external stakeholders, including patients and healthcare professionals,… more
- Cipla (Hauppauge, NY)
- …SOPs, and other documents related to manufacturing processes. Ensure batch records are audit -ready and fully compliant for both internal and external audits (eg, ... complies with Good Manufacturing Practices (GMP), regulatory standards, and internal quality assurance procedures. This role ensures the integrity, accuracy,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Coordinate document reviews, approvals, and revisions, ensuring timely updates and compliance with internal and external requirements Monitor and track ... against established metrics Prepare and present regular reports on documentation compliance , audit results, and improvement initiatives to senior management… more
- Vaco by Highspring (Boston, MA)
- …and report audit results in accordance with professional standards for internal auditing Assess processes and internal controls are appropriately designed ... and operating effectively to mitigate financial, operational, regulatory and compliance risks Plan and execute testing of Internal Controls over Financial… more
- Insmed Incorporated (NJ)
- …end-user training to ensure consistent and compliant execution across Patient Services.Lead audit readiness and inspection management for internal QA, client, ... leads quality assurance and process improvement initiatives to ensure compliance , consistency, and operational excellence across Insmed's patient services programs.… more
- Cipla (Reid, WI)
- …River, MA Work Hours: General Shift: 8:30AM - 5:00PM (may vary based on business needs) Reports To : Department Head - Manufacturing Salary Range: $72,800 - $93,600 ... Manufacturing and partners with cross functional team members to ensure compliance and operational success through user focused documentation at InvaGen… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Position The position is responsible for gross-to-net forecasting for the US business , ensuring external and internal customer alignment as necessary. The ... next Generation platforms, current generation model enhancements and creation/implementation of Business Intelligence platforms Serve as internal consultant with… more
- Merck & Co. (Durham, NC)
- …Documentation Review, Driving Continuous Improvement, Environmental Monitoring, GMP Compliance , IS Audit , Multidisciplinary Collaboration, Problem Solving, ... of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an… more
- Eisai, Inc (Nutley, NJ)
- … business '; lead global initiatives for continuous improvement.Trend and leverage internal audit and industry intelligence relating to inspections and share ... and execution of the global Clinical Quality Assurance (CQA) strategy including audit and inspection management, issue management and oversight of the Quality… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …sources. The Director is responsible for mentoring coaching and meeting the compliance requirements for the Medical Review Team. Relationship Reports directly to ... and Strategy for case-related risks and operational challenges Collaborate with internal stakeholders to proactively identify and mitigate potential issues … more
- Insmed Incorporated (NJ)
- …Investigator Brochures, and handling guidanceSupport Clinical Supply Chain to ensure compliance with eTMF documentation and audit readiness activitiesSupport ... manage strategic supplier relationships, lead vendor selection, performance monitoring, business review governance, and continuous improvement reviewsEstablish and maintain… more
- Cipla (Hauppauge, NY)
- …with Good Manufacturing Practices (GMP) and regulatory requirements. Participate in internal audits and ensure compliance with warehouse quality standards. ... 5:00pm Job Overview: The QA Inspector (Warehouse) ensures the quality and compliance of printed packaging materials and warehouse operations. This includes reviewing… more
