- Daiichi Sankyo, Inc. (Bernards, NJ)
- …stakeholders if the acceptance criteria for each vendor is reached as per internal procedures. Audit Intelligence and Metrics: Accountable to create and maintain ... rare diseases and immune disorders. Summary: Accountable to organize and directs an audit universe for GMP relevant activities involving but not limited to supplier… more
- 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 ... identifying, assessing and monitoring all aspects of change management risk . Internal Controls Experience (Nice to Have):...the ability to develop innovative ideas and scope engagements. Risk Assessment & Audit Proficiency: Experience in… more
- AdaptHealth LLC (Philadelphia, PA)
- …and Control Evaluation: Conduct comprehensive risk assessments and evaluate internal control frameworks across business units. Prepare audit testing ... - Business Systems is responsible for supporting and executing internal audit engagements, initiatives, and projects across...Skills, and Abilities: Audit Expertise: Knowledge of internal control frameworks (COSO, SOX), risk assessment… more
- Merck & Co. (Durham, NC)
- …Director/GMP Lead Site Auditor will have leadership responsibility for the site internal audit program, encompassing the full scope of site operations.- ... position requires ability to lead and perform the operational aspects of the audit program, apply risk -based principles, communicate results to stakeholders, and… more
- Repligen (Waltham, MA)
- …program, advises on risk mitigation strategies, and partners closely with Internal Audit , IT, Financial Reporting, and external auditors to strengthen ... SOX processes.Utilize data analytics to enhance testing quality, reduce risk , and improve audit coverage.Stay current on...frameworks (COSO, COBIT, NIST).Act as the primary liaison with internal teams, Internal Audit , and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …program implementation across all sites.Manage and support the implementation of the internal and external audit program.Schedule, execute, report and follow-up ... other internal functions to understand and mitigate any compliance risk and establish vendor quality scorecard.Support development and gathering of quality… more
- Cipla (Fall River, MA)
- …and review elemental impurities risk assessment and nitrosamine related risk assessment. Prepare audit reports, documenting findings, and provide actionable ... InvaGen Pharmaceuticals Plant Quality Team. This role ensures compliance with both internal and external quality standards at Invagen Pharmaceuticals Inc. Fall River… more
- Merck & Co. (Omaha, NE)
- …policies, procedures, and related training. The Specialist will interface with internal customers, external vendors, and service providers as needed. This role ... audits of our Company's global export and import operations and generate audit reports.Assist local sites in developing robust CAPA plans with realistic… more
- Merck & Co. (Rahway, NJ)
- …Business Services on close and reporting mattersAudit support:Respond to audit inquiries, and support internal /external auditorsLeadership and ... and compliance:Ensure adherence to US GAAP, company finance policies, and internal control requirementsOwn and enhance SOX key controls, documentation, and testing… 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
- Insmed Incorporated (NJ)
- …and maintain KPIs, scorecards, and governance frameworks for both internal supply operations and external partnersServe as clinical supply representative ... teams; translate protocol design into demand/supply plans, contingency strategies, and risk mitigation across global marketsSupport the development and monitoring of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …process.Support manufacturing activities for cGMP compliance through spot checks/ internal audits.Collaborate with site personnel to provide guidance and ... & 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… more
- Cipla (Fall River, MA)
- …deviations. Develop, implement and assess solutions for complex problems. Anticipates risk and builds contingencies to help mitigate impact. Reviews document for ... assuring new documents have been entered using appropriate protocols. Follows strict internal protocols and Standard Operating Procedures (SOPs) as well as following… more
- Insmed Incorporated (San Diego, CA)
- …through participating in release management, change control, periodic reviews, and audit trail reviews. \tOnsite at San Diego site.What You'll Do: Responsibilities ... Provide strategic leadership and decision making on CSV strategy Develop risk -based validation strategies for system implementation and changes following CSV SOPs… more
- Cipla (Fall River, MA)
- …deviations. Develop, implement and assess solutions for complex problems. Anticipates risk and builds contingencies to help mitigate impact. Reviews document for ... documents have been entered using appropriate protocols. Follows strict internal protocols and Standard Operating Procedures (SOPs) as well...of p reparation of SOP and eLog books. During audit part of team. Planning of batches as per… more
- Insmed Incorporated (NJ)
- …through participating in release management, change control, periodic reviews, and audit trail reviews.What You'll Do: Provide strategic leadership and decision ... making on CSV strategy using Insmed's risk -based approach. Provide oversight and manage multiple projects at the same time. Provide operational support like change… more
- Insmed Incorporated (NJ)
- …through participating in release management, change control, periodic reviews, and audit trail reviews.What You'll Do: Develop risk -based validation strategies ... with cloud-based systems and SaaS validationStrong customer service skills for internal and external customers and comfortable working in cross functional… more
- The H&K Group (Skippack, PA)
- …and Calendar Management: Coordinate and manage the training calendar, scheduling internal and external instructors, securing training rooms or virtual platforms, and ... modules, updating content, managing user profiles, troubleshooting access issues, audit recurring training, and reviewing feedback/continuous improvement. Record Keeping:… 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 ... job evaluation methodology to assess and manage job levels, ensuring internal equity and alignment with organizational structure; support compensation benchmarking… more
- Rutland Regional Medical Center (Rutland, VT)
- …system of internal controls and accounting records designed to mitigate risk , ensure the accuracy and timeliness of financial reporting, and maintain compliance ... hold a supporting role within the board finance, investment, and audit committee. A strong understanding of healthcare reimbursement methodologies, cost reporting,… more
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