- Insmed Incorporated (Bridgewater, NJ)
- … regulatory GMPs and global company policies & proceduresLead overall management of Quality Assurance programs to support the QC lab and to ensure they ... in other departments to increase the overall effectiveness of the Quality Assurance department.Support Statistical Trending of Manufacturing and Analytical… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …or a leading international regulatory agency preferred As applicable, experience with Quality Assurance oversight and support for all phases of Clinical and ... records to certify compliance with specifications and procedures Releases product based on Quality Assurance record review and approval by QA Manager Performs… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …documentation Reviews and assesses deviations; includes tracking, follow-up and reporting /trending Reviews manufacturing and support records to certify compliance ... with specifications and procedures Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, walk through audits of… more
- Merck & Co. (North Wales, PA)
- …processes to ensure robust Quality oversight Preferred: Experience in both Quality Assurance and Quality controlExperience in external manufacturing / ... Management System (QMS) elements, procedures, and systems to ensure quality and regulatory compliance with Current Good...external quality assurance or alliance managementExperienced in interacting with regulatorsAdvanced degree… more
- Catalent (Harman, WV)
- …biologic, pharmaceutical or medical device industry performing direct hands-on work in a Quality Assurance / Quality Control function with a strong familiarity ... independently under minimum supervisionAbility to work in fast paced environment supporting the quality assurance / quality control departments of a CMO for… more
- Merck & Co. (North Wales, PA)
- …holder through the entire product lifecycle.Key areas of focus include:the assurance of deliverable quality and process compliance,effective deliverable ... industry best-practices.Experience in CDISC and ADaM standards.Demonstrated success in the assurance of deliverable quality and process compliance.Ability to… more
- Merck & Co. (North Wales, PA)
- …and providing tools and templates to support delivery focusing on traceability, quality assurance , data conformance and data fitness. The position is ... (SDTM), provides oversight and creation of the SDTM deliverables for analysis and reporting and world-wide regulatory application submissions of drug and vaccine… more
- Merck & Co. (North Wales, PA)
- …DescriptionThis position provides high quality statistical programming analysis and reporting and regulatory submission deliverables for Real World Evidence ... in a variety of formats with minimal requirementsDemonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge… more
- Aequor (Seattle, WA)
- …site. Generate document management system reports for Quality Council metric reporting . Support internal and external audits and regulatory inspections if ... great communication - Experience working cross-functionally Position Summary: The Quality Assurance Document Control (QADC) Associate Specialist supports… more
- Merck & Co. (Rahway, NJ)
- …management and is accountable to set strategy for the delivery of high quality and compliant statistical analysis and reporting .Direct the activities of ... level ensuring that project plans are executed efficiently with timely and high- quality deliverables.Manage the analysis and reporting deliverables of Functional… more
- Merck & Co. (North Wales, PA)
- …to anticipate stakeholder requirements.Preferred Experience: Demonstrated success in the assurance of deliverable quality and process compliance. Strong ... 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)
- …experience in clinical research (eg, monitoring, data management, clinical quality assurance , study management)Experience with risk management tools ... It is business critical that our company receives consistent, accurate, high- quality data from clinical trials conducted worldwide. REAIM ( Risk Evaluation… more
- Novo Nordisk Inc. (Boulder, CO)
- …& other stakeholders, & presentation in steering groups Support local Quality Assurance unit activities Business Process Improvements: Manage activities ... to support analytical and process development, the CMC team works alongside Quality , Regulatory , Technical Operations and RNAi Early Development professionals at… more
- Merck & Co. (Ames, IA)
- …needed, to aid in delivery of product to customers, ie International Registration, Quality Control, Quality Assurance , Production, etc.Provide Sales force ... and adverse reports in accordance with internal, FDA, CFIA and USDA regulatory policies.- The position will require developing trial protocols, monitoring and… more
- Merck & Co. (North Wales, PA)
- …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. (Rahway, NJ)
- …efficient solutions.Define and enforce coding standards, development methodologies, and quality assurance processes.Drive innovation in SAP development ... for the aforementioned areas, as well as SAP Middleware/Integration and Reporting /Analytics standards, patterns, and technologies.- They will lead the Technology… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …have relevant working experience in an aseptic manufacturing facility, preferablyin quality assurance , manufacturing compliance, clinical quality , technical ... batch records. Real time review of all documentation and reporting in support of process unit operations and release...tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Support regulatory … more
- Mizuho Corporate Bank (New York, NY)
- …complex financial institution in performing financial and/or regulatory reporting , regulatory reporting quality assurance , or internal audit; + ... Quality Assurance Unit: The Quality ...for enhancing the integrity of the financial regulatory reporting processes, reporting data quality as… more
- SMBC (Jersey City, NJ)
- …SMBC offers a competitive portfolio of benefits to its employees. **Role Description** The Regulatory Reporting Quality Assurance Director role is ... Reporting (including FR 2052a, Liquidity Coverage Ratio) Market Risk regulatory reporting (eg, FFIEC 102), and CCAR (eg, FR Y-14A) + Responsible for… more
- Broadview FCU (Albany, NY)
- …timely service to BFCU, effective and efficient use of resources, regulatory reporting , and quality assurance . + Develop and provide monthly reports ... the right place! Overview of the Role The VP, Regulatory Monitoring & Reporting manages the daily...7 years' relevant managerial experience in a complex compliance, assurance , or risk function + Expert knowledge of internal… more
