- Legend Biotech USA, Inc. (Raritan, NJ)
- …the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Quality Compliance Lead as part of the Quality team based in ... Raritan, NJ. Role Overview The Quality Compliance- Lead Auditor CAR-T is responsible...quality system areas for the manufacturing site; write audit reports, issue audit observations and follow-through… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …withstand the scrutiny and questioning of a sponsor pre-approval inspection.Post inspection, audit , quality review , investigational panel or other identified ... centered around rare diseases and immune disorders. Summary The Manager, Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is responsible to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and global Quality expectations. Partner with global Quality departments to review global policies, inspections and audit CAPAs, and vendor audit ... expertise and solutions to CSV questions and issues.Responsibilities- Provide Validation Lead support for Daiichi Sankyo GxP and Non-GxP computer systems… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas/process improvement to stakeholders via the QMS scheme (ie, Quality Management Review , Quality Review Board) across the global CSPV organization ... for tactical and strategic GVP audits are in place. Review risk assessment documents stemming from audit ...lead as the Head of PV QA with Quality Reviews of respective product profile to ensure appropriate… more
- Eisai, Inc (Nutley, NJ)
- …incidents.Conduct annual tests and address vulnerabilities.Analyze threat data and lead hunting efforts.Deploy standards, conduct training, and track KPIs.Define ... critical processes and manage recovery testing.Regularly review adherence to standards.Oversee regional security vendors.Prioritize risk-based reduction… more
- Catalent (Philadelphia, PA)
- …Philadelphia, PA is hiring a QA Supervisor. The QA Supervisor will p rovide Quality Assurance support for the Quality Inspectors on the production floor, ... incoming material quality , and/or distribution quality , including quality oversight for material management of materials at Catalent-Philadelphia. Assist in… more
- Catalent (Philadelphia, PA)
- Quality Assurance Document Control Supervisor Position Summary Catalent Pharma Solutions in Philadelphia, PA is hiring a Quality Assurance Document Control ... facilities. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Management:Responsible for the ownership and maintenance of GCO-owned procedural document packages. Lead authoring, review , and periodic reviews/updates for all ... the creation, management, and documentation of GCO's CRO SOP review and maintaining the master Daiichi Sankyo (DS) SOP...support for GCO process improvement activities, projects, inspections and/or audit findings resulting in the need for either a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and LeadershipHas primary accountability for operational study-level timeline, cost, and quality deliverables. Lead the development of the clinical study plan ... planning start-up, conduct, reporting and close out) including timeline, quality and budget. A key focus will be the...trial progress and bring deviations to the Operational program Lead and study team leader. Review and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …& Leadership Has primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan ... and vendors.Provide operational input into study protocol profiles, final protocols and amendments. Lead document review & coordination for the protocol and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to operational delivery aspects of the protocol and take a document review & coordination role for the protocol and amendments. Additional medical writing ... functional integration and delivery of items (eCRF, EDC, IXRS, Quality Oversight Plan etc) per the study plan. Oversee...implemented. Liaise with CRO to support database lock and review of TLG before and after database lock.Ensure DS… more
- Catalent (St. Petersburg, FL)
- …quarterly and annual summaries and metrics, including DRB (Deviation Review Board) presentation.Effective communication with Quality Assurance Supervisor ... I. Department Overview: The Quality Assurance Department is responsible for providing leadership...solutions. Furthermore, this position will participate in the internal audit program, customer audits and may assist with Supplier… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Standard Operating Procedures (SOPs) for equipment operation. Conduct regular reviews of system audit trails / periodic review to ensure data integrity and ... Legend Biotech is seeking QC Specialist, Equipment Management as part of the Quality team based in Raritan, NJ. Role Overview The QC Specialist, Equipment Management… more
- Aequor (Thousand Oaks, CA)
- …Details: Owns and Manages Change Control Records. Owns and Manages Deviations, and Lead Root Cause Analysis. Develops, writes, edits, and formats materials such as ... guidelines, giving consideration to usability and ensuring accuracy, consistency and quality . Maintain data accuracy and perform data analysis for Management reviews… more
- The Cigna Group (Houston, TX)
- **Job Summary:** The Medicare Coding Quality Review Audit Manager is responsible for day-to-day oversight of the Risk Adjustment coding quality assurance ... adjustment coding initiatives and collaborates with matrix partners to lead and develop a sustainable, repeatable and quantifiable process...solutions are performed as designed + Works closely with Quality Review Audit Advisor to… more
- Elevance Health (Columbus, OH)
- **Internal Audit Manager/ Lead ** Elevance Health supports a hybrid workplace model (virtual and in-office) with PulsePoint sites used for collaboration, ... in office days 1-2 times per week. The Internal Audit Manager/ Lead is responsible for independently leading,...duties may include, but are not limited to:** + Lead the development and execution of high- quality … more
- Bank of America (Atlanta, GA)
- …+ Strong preference to having Audit experience **Skills:** + Analytical Thinking + Audit Planning + Internal Audit Review + Issue Management + Risk ... Audit Supervisor - Corporate Audit and Credit Review Atlanta, Georgia;Wilmington,...automation and innovative methods in a timely and high quality manner + Exercises sound knowledge of product, business,… more
- US Bank (New York, NY)
- …skills and discover what you excel at-all from Day One. **Job Description** The Audit Methodology Lead supports the Head of Professional Practices and the ... Professional Practices Senior Audit Manager in maintaining the Corporate Audit ...revised IIA standards, guidance, and publications; make recommendations and lead the implementation of any action plans. + Perform… more
- System One (Philadelphia, PA)
- Job Title: Lead Auditor, Audit and Quality ... report documents as required per CTMB guidelines. * Review audit findings for compliance per GCP, OHRP, ... data management * Experience with NCTN clinical trial operations, data management, audit , and quality assurance is preferred. Education * Bachelor's degree… more
- USAA (Charlotte, NC)
- …management of models for high risk and highly complex models. Executes the model audit review process compliant with the written risk and compliance policies and ... plans and provides feedback on model tests and data quality assessments for models using various types of datasets...+ Produces and delivers model workpapers and related model review documentation to model risk audit management,… more
