- Repligen (Waltham, MA)
- …manage Supplier Change Notifications to ensure compliance with internal and regulatory quality standards.Coordinate cross-functional teams to assess and mitigate ... issues through appropriate channels, ensuring long-term risk mitigation and product quality assurance .Qualifications Bachelor's degree in engineering, Quality… more
- BioAgilytix (Durham, NC)
- …for data quality , access control, and compliance protocols.Define standards, build quality assurance processes, and monitor data integrity to meet ... LIMS and ERP systems.Proven ability to define data standards, develop and implement quality assurance processes, and ensure data integrity in alignment with … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategic collaboration with other GxP Quality representatives, and act as the Quality Assurance point person for all GxP matters within the Medical Affairs ... other research areas centered around rare diseases and immune disorders. Job Summary: Reporting to the Sr. Director, Medical Affairs QA, the Director of Medical… more
- Merck & Co. (North Wales, PA)
- …team.Experience in CDISC and ADaM standards and demonstrated success in the assurance of deliverable quality and process compliance also required.Must possess ... drug/vaccine clinical development projects.Develop and execute statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables,… more
- Merck & Co. (Rahway, NJ)
- …management conceptsExperience in CDISC and ADaM standardsDemonstrated success in the assurance of deliverable quality and process compliance.Strategic thinking - ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (North Wales, PA)
- …stakeholder requirements Preferred Skills and Experience: Demonstrated success in the assurance of deliverable quality and process compliance. Strong working ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and clinical project management competencies within Clinical OperationsWork in collaboration with Quality Management and Quality Assurance to develop and ... aspects of clinical study planning, implementation, data delivery and reporting . Will represent DSPD Clinical Operations in a range...studies are conducted according to the timeline, budget and quality measures set forth by the Study teams. This… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …quality experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , technical ... a QA Shop Floor Specialist as part of the Quality Operations team based in Raritan, New Jersey. Role...for manufacturing issues.Real time review of all documentation, and reporting , in support of process unit operations, in accordance… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. Role OverviewThe QA...OverviewThe QA Investigation Lead is an exempt level position reporting to the QA Investigation Supervisor within the Raritan… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … Quality , Legal, CMC, MSAT, Manufacturing, Supply Chain, and Regulatory to prepare alternate/secondary sourcing strategies.Achieve cost savings objectives for ... of a rapidly expanding, commercialized CAR-T product portfolio. This position will be reporting to Head of Global Sourcing and will develop and execute a long-term… more
- Formation Bio (New York, NY)
- …obligations to maximize service quality and efficiency. Partner with Legal, Quality Assurance and Data Governance teams to understand and monitor vendor ... savings, contract optimizations, and risk mitigation. Implement procurement analytics and reporting tools to provide visibility into vendor spend and procurement… more
- Citigroup (Tampa, FL)
- …to be part of the Regulatory Reporting & Client Tax Operations Quality Assurance (QA) team in our Wealth division. The Global Regulatory ... support rolling out and implementation of the quality assurance framework for all regulatory reporting & Client Tax across multiple jurisdictions,… more
- American Express (Sandy, UT)
- …and oversight of regulatory reporting process. The team performs Quality Assurance reviews including process & controls testing, testing the conformity ... technology, data governance, service management, teams to ensure quality assurance over the regulatory reporting processes. + Support regulatory … more
- Huntington National Bank (Columbus, OH)
- …report on the level of data quality . Lead performer on data quality activities that support key compliance and regulatory processes. Perform data discovery, ... data quality + Lead performer on data quality activities that support key compliance and regulatory...the Record to Report (R2R) cycle, and the management reporting cycle. Exempt Status: (Yes = not eligible for… more
- Highmark Health (Harrisburg, PA)
- …related system development projects. Responsibilities may include: analysis, audits, compliance and regulatory reporting , quality assurance , interaction ... management. + Assists with employee data auditing and compliance reporting . + Assists in the preparation and management of.... + Assists in the preparation and management of regulatory and compliance requirements + Provide project and analytical… more
- Mount Sinai Health System (New York, NY)
- **Job Description** ** Quality and Regulatory Specialist MSH Quality Assurance FT Days** The Quality and Regulatory Specialist facilitates and ... CPHQ, Lean Six Sigma preferred Non-Bargaining Unit, 535 - Quality Assurance - MSH, Mount Sinai Hospital...education on improvement methodologies. Serve as a liaison with regulatory data abstraction and reporting . ** Regulatory… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …ZOLL the ideal place to build your career.Job SummaryDirects the activities of the Quality Assurance and Regulatory Affairs department. Ensures the ... quality and regulatory systems are effectively implemented and maintained.Essential Functions +...and international markets. + Post-market surveillance and medical device reporting in domestic and international markets + Responsible for… more
- Highmark Health (Pittsburgh, PA)
- …procedures, processes, and technology based on the identification of legislative, regulatory , sub- regulatory , and licensing / accreditation requirements from the ... the Board of Directors as required. + Create and execute complex regulatory implementation strategies for assigned legislative, regulatory , sub- regulatory ,… more
- Citigroup (New York, NY)
- …value across T&BE organization and oversees Controls, Analytics and Decision Management, Quality Assurance , Regulatory Management, Data and Transformation ... regulatory commitments across T&BE globally. The Data Quality Assurance Lead will be a key...solutions. + Support T&BE QA Director (QAD) to publish quality and on-time QA status reporting to… more
- Guidehouse (Bethesda, MD)
- …the QA/I program as required by accreditation organizations to ensure Quality Assurance Program reviews comply with regulatory agency standards. + Assist in ... Public Trust We are currently searching for a Clinical Laboratory Scientist with quality assurance experience to provide support to the National Institutes of… more
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