- Insmed Incorporated (NJ)
- …in. Are you?About the Role:We are seeking a highly motivated and expert Executive Director, Internal Audit & SOX (ED, IA) to lead our internal audit function ... they advise on value-creating opportunities in strategic and operational areas.What You'll Do: Lead the internal audit function, developing and executing on the… more
- Merck & Co. (Rahway, NJ)
- …to what is described in the Pipeline Advertisement.Expand your skills and experience in audit through a career path in the pharmaceutical industry. Become part of a ... impact on patients' lives.Under the direction of the Client Audit Director (CAD) and the Auditor-in-Charge (AIC), the Senior...our company.On occasion, the incumbent will be expected to lead small teams of auditors audits with limited management… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company's Audit and Assurance Services primary purpose is to provide value-added independent and risk-based audit and assurance ... Overview / Function and ResponsibilityUnder the direction of the Client Audit Director ("CAD") and the Auditor-in-Charge ("AIC"), the Senior Specialist… more
- Eisai, Inc (Nutley, NJ)
- …excess coverage) for a marketed product across all relevant insurance lines; Lead audit calculations for premium adjustments; Manage the end-to-end process ... mitigate financial risks related to currency, interest rates, and other factors; lead communication within Eisai to ensure adherence to Treasury Policies and reduced… 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 ... to sponsors.Automate Delivery Workflows: Leverage RPA, scripted edit checks, and audit -trail capture to shrink cycle times and reduce defects.Enable Self-Service… more
- Jazz Pharmaceuticals (Redwood City, CA)
- …responsible for the execution of issue management processes, assisting and/or leading audit and inspection processes and preparing for governance meetings to achieve ... partnerships. Partner with GRADS Compliance Regulatory and Labeling Partner to lead in the compliance analysis in complex Regulatory Affairs, Regulatory Operations… more
- Tris Pharma (Monmouth Junction, NJ)
- …transactions while implementing rigorous controls to reduce errors and support audit readiness including, but not limited to: overseeing and supporting daily ... and documentation; Drafts white papers and accounting memos to support audit and regulatory compliance Provides guidance on new accounting pronouncements, as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …transfer of PV Business in case of Product Divestment. Collaborate with DSI audit groups to ensure comprehensive auditing of Business Partners as required to assure ... compliance with PV agreements. Participate in audit and inspection readiness activities. Provide input for remediating PV system deficiencies cited in audit… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …local inspections by providing adequate systems and process support, ensuring seamless execution. Lead lessons learned efforts based on audit findings, inspection ... of successful Health Authority inspections and approvals - Proactively partner and lead the strategic collaboration with other GxP Quality representatives, and act… more
- Merck & Co. (Rahway, NJ)
- …Director, will report to the Animal Health Global Quality Compliance and Technical Lead .-- The responsibility of this position is across all Animal Health operating ... guidelines, customer requirements, SOPs and project specific guidelines/ instructions.Evaluate audit findings and ensure timely identification/ escalation of potential… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …departments in relation to department objectives. Essential Functions Leadership & Oversight Lead and manage the global Case Processing team, fostering a culture of ... metrics to ensure departmental KPIs and regulatory compliance are consistently met Audit & Inspection Readiness Support the preparation and execution of internal and… more
- Cipla (Fall River, MA)
- …to cGMP and set standards to meet the regulatory requirement and to ensure audit readiness. Monitor material is stored as per proper storage condition with required ... Maintain sanitation and hygiene in stores facility to ensure audit readiness Ensure correct status labelling for materials, accessories...believes that our biggest assets are the employees, who lead us to prosperity and growth in the future.… more
- Cipla (Central Islip, NY)
- …other changes of any Pharmacopoeia are in effect. Review of laboratory audit trials during data review against standard operating procedures (SOPs). Coordinating ... equipment operation, qualification and calibrations which includes their software audit trial reviews. Eg HPLC, UV Vis Spectrophotometer, GC,...believes that our biggest assets are the employees who lead us to prosperity and growth in the future.… more
- Eisai, Inc (Nutley, NJ)
- …and execution of the global Clinical Quality Assurance (CQA) strategy including audit and inspection management, issue management and oversight of the Quality ... Clinical Quality Assurance (CQA) strategy for the country/region in scope (including audit and inspection management, issue management, and oversight of the quality… more
- Cipla (Reid, WI)
- …leads and manages projects to implement continuous improvement opportunities. Lead and/or support root cause investigations related to performance trends ... of p reparation of SOP and eLog books. During audit part of team. Planning of batches as per...believes that our biggest assets are the employees who lead us to prosperity and growth in the future.… more
- Aequor (Thousand Oaks, CA)
- …general supervision, provide tactical support activities to Quality Management System Lead . Specific responsibilities include but are not limited to: Manage the ... Digital QMS platform for health and control processes. Leads Digital QMS audit & inspection readiness, deviations and change control activities Manage Organizational… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … audit results, and improvement initiatives to senior management Lead continuous improvement initiatives related to GxP documentation processes, leveraging ... of Customer Engagement Programs, and other CMR Functional areas. This job will lead a team of Patient Safety training and vendor training oversight managers and… more
- Walking Mountains Science Center (Avon, CO)
- …organization's ability to meet its fiscal obligations and fulfill its mission. Manage the Annual Audit (early Fall): Train to lead on our Annual Audit , ... internal financial reporting, store inventory counts, eventually leading the Annual Audit and Budget Process, and maintaining GAAP standards and well-kept internal… more
- Genscript USA Inc. (Piscataway, NJ)
- …supply continuity, compliance with quality and regulatory standards, and readiness for audit requirements. The estimated salary range is $80,000 - $100,000, based on ... item replenishment to meet inventory KPIs while ensuring continuity of supply. Lead strategic sourcing and manage the procurement process for direct materials and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with Promotional Review Board as required. Essential Functions Leadership & Oversight Lead and manage the Medical Review Case Processing team, fostering a culture ... audits and regulatory inspections Ensure documentation and processes are audit -ready and aligned with global pharmacovigilance standards Physical Requirements 0-10%… more
