- Usaa (Plano, TX)
- …may be substituted in lieu of a degree. 6 years relevant experience in risk , compliance, legal or audit within the financial services or insurance industry ... with the ability to develop innovative ideas and scope engagements. Risk Assessment & Audit Proficiency: Experience in performing risk assessments and… more
- Insmed Incorporated (NJ)
- …of documentation, audit readiness, and continuous improvement of CSV processes. Risk Management: Define and implement risk management policies and frameworks ... presenting to Executive Management and Boards of Directors .Strong understanding of risk management, compliance, and audit processes within regulated industries,… more
- Unknown (Los Angeles, CA)
- …the manufacturing space. The ideal candidate will ensure financial integrity, compliance, and risk oversight while leading the Audit Committees and serving as a ... Senior Advisors in driving the success of portfolio companies. The Senior Advisor, Audit Chair role requires an accomplished senior finance leader with a strong… more
- Repligen (Waltham, MA)
- …over financial reporting and key digital systems. This role drives the ITGC audit program, advises on risk mitigation strategies, and partners closely with ... ITGC and SOX processes.Utilize data analytics to enhance testing quality, reduce risk , and improve audit coverage.Stay current on regulatory requirements (SOX,… more
- Cipla (Fall River, MA)
- …and review elemental impurities risk assessment and nitrosamine related risk assessment. Prepare audit reports, documenting findings, and provide actionable ... (eg, quality metrics, CAPA (Corrective and Preventive Action) reports, audit findings). Support investigations of deviations, non-conformances, and customer… more
- Merck & Co. (Durham, NC)
- …position requires ability to lead and perform the operational aspects of the audit program, apply risk -based principles, communicate results to stakeholders, and ... evaluate/verify CAPA closure.- Position requires risk communication related to the totality of audit and inspection findings at the site.- Ability to lead an … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary: Accountable to organize and directs an audit universe for GMP relevant activities involving but not limited to supplier ... qualification program, CMC audit , clinical/IMP vendor audits and overall GMP vendor ...program to ensure adequate qualification of auditors per regulatory expectations. Risk Management and Vendor Performance: Responsible to ensure the… more
- Zoltek-Toray Group (St. Louis, MO)
- …review documentation, identify gaps, and implement corrective actions to mitigate risk and maintain audit readiness. Draft, coordinate, and distribute ... organizational announcements including promotions, new hires, policy updates, and company-wide communications Other duties as assigned. Qualifications: Bachelor's Degree in Human Resources, Business Administration, or related field Minimum 5 years of… more
- AdaptHealth LLC (Philadelphia, PA)
- … audit execution while developing expertise in control evaluation, risk assessment, and regulatory compliance frameworks. Essential Functions and Job ... cross-functional teams including Finance, Legal, IT, and Operations. Lead discussions regarding audit observations and promote awareness of risk and control… more
- Merck & Co. (Omaha, NE)
- …audits of our Company's global export and import operations and generate audit reports.Assist local sites in developing robust CAPA plans with realistic ... in continuously improving our Company Animal Health trade compliance risk level. Education Requirements: High school diploma required.Bachelor's degree preferred.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …all sites.Manage and support the implementation of the internal and external audit program.Schedule, execute, report and follow-up on internal and US and Global ... external audits (travel required).Ensure audit observations are communicated, tracked, and remediated in compliance with internal policies and procedures as well as… more
- Merck & Co. (Rahway, NJ)
- …Services on close and reporting mattersAudit support:Respond to audit inquiries, and support internal/external auditorsLeadership and development:Provide day-to-day ... reserves, and period-end analyticsControls: SOX design and operating effectiveness, risk assessment, documentation, and remediationBusiness partnering: Influencing, stakeholder management,… more
- Insmed Incorporated (NJ)
- …and environmental protection for all Insmed locations.Key duties include risk assessment, developing safety policies, managing training programs, and ensuring ... all Insmed locations and functions. The position will be responsible for minimizing risk to employees, visitors within operational lab assets or in office settings.… more
- AUROBINDO (Durham, NC)
- …execute CSV protocols (IQ, OQ, PQ) for GxP systems.Prepare Validation Plans, Risk Assessments, and Traceability Matrices.Ensure compliance with FDA 21 CFR Part 11, ... system implementation and upgrades.Manage change control for validated systems.Support audit readiness and respond to regulatory inspections.Train stakeholders on… more
- Insmed Incorporated (NJ)
- …teams; translate protocol design into demand/supply plans, contingency strategies, and risk mitigation across global marketsSupport the development and monitoring of ... Clinical Supply Chain to ensure compliance with eTMF documentation and audit readiness activitiesSupport regulatory filings (IND/CTA/IMPD), act as SME during… more
- Christus Health (Grand Prairie, TX)
- …statements. The Lead Accountant will typically be assigned to areas of higher risk and more complex accounting within the functional accounting team. They are ... on the assigned functional team. The Lead Accountant will be assigned lower risk areas to review journal entries and balance sheet reconciliations. The Lead… more
- Merck & Co. (Rahway, NJ)
- …working level.#eligibleforERP#PSCS#GCScareerGCSopsRequired Skills: Accountability, Accountability, Audit Preparations, Business Process Improvements, Clinical ... Medical Supply Management, Motivating Teams, Negotiation, Operational Excellence, Operational Risk Assessment, Outsourcing, People Leadership, Problem Solving, Process Optimization… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …& material release in SAP for In-house reagents.Support Floor Spot-check, audit trail review.Strive to reduce non-conformances in supported areas by proactively ... effectively determine appropriate resolutions that ensure compliance and minimize risk .Ability to collaborate well with stakeholders, customers and peers.Must… more
- Twist BioScience (South San Francisco, CA)
- …ensure project is on trackMeasure project performance and assist with project risk managementReport project status, risks, and escalations Work with product owners ... CLIA, etc.), with involvement in documentation, validation planning, or audit preparationFamiliarity with eCommerce platforms and Business Applications such as… more
- Cipla (Central Islip, NY)
- …control documents Review of system records Perform activities related to periodic audit trail review of all quality softwares, ensure compliance within the systems ... Maintaining regulatory compliance in accordance with cGMP and Perform Data Integrity risk assessment of current Good Manufacturing Practices (cGMP) and GLP systems… more
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