- Merck & Co. (Upper Gwynedd, PA)
- …related pharmaceutical operations (eg, manufacturing, formulation and process development, analytical, quality assurance , n ovel modality and technologies such ... CMC - Associate Principal Scientist, CMC, R4 - Pharm Pre-approval Reporting to the Sr Director/Director/Principal Scientist/Sr Principal Scientist in Pre-approval… more
- Merck & Co. (Rahway, NJ)
- …process and providing tools and templates to support delivery focusing on traceability, quality assurance , data conformance and data fitness. The position is a ... with SAS and Python Programming for SDTM Conversions.Demonstrated success in the assurance of deliverable quality and process compliance.Excels in technical… more
- Eisai, Inc (Raleigh, NC)
- …the Eisai Raleigh facility. This position is responsible for executing core quality assurance functions, supporting regulatory inspections, and collaborating ... of combination products and/or Biologics is a plus). Demonstrated experience across applicable quality assurance functions in a GMP setting (eg, batch record… 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
- 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
- Twist BioScience (South San Francisco, CA)
- …closely with the platform architecture and infrastructure teams, Manufacturing Operations, Quality Assurance , Process Development, and Regulatory Affairs ... MES professionals, primarily software developers, who work in concert with Manufacturing Operations, Quality Assurance , and R&D. The Director will serve as the… more
- Aequor (Thousand Oaks, CA)
- …management when appropriate. Reviewing protocols for manufacturing activities and partnering with Quality Assurance to ensure that GMP standards are maintained ... to peers and senior leadership team. Additional Responsibilities include: Engaging with Quality and Regulatory teams to ensure alignment and compliance across… more
- Merck & Co. (North Wales, PA)
- …requirements - ** Preferred Skills and Experience: Demonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- AUROBINDO (Durham, NC)
- …of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to ... customs and the FDA. The position is also required to work closely with Quality Control to make sure that the process flows smoothly from receiving the product… more
- Insmed Incorporated (San Diego, CA)
- …strategies.Facilitate collaboration with both internal and external drug substance analytical, quality control, quality assurance , and manufacturing ... scale-down models for biopharmaceutical processes, including interpretation of results and reporting that stands up to regulatory inspection.Demonstrated expert… more
- Aequor (Thousand Oaks, CA)
- …on new technologies and ensure smooth integration into new and/or modified processes Regulatory Compliance and Quality Assurance : Ensure all data management ... of working Implement best practices in data collection, cleaning, and reporting including knowledge of Pinnacle 21, Centralized Statistical Monitoring, Quality… more
- Eisai, Inc (Exton, PA)
- …with other Development groups as well as with Facilities, Quality Assurance , Quality Control, Regulatory , and CMC Program Management departments.The ... Interact cross-functionally with Support Services, Facilities, Biologics Process Development, Quality Assurance , Quality Control, Validation, and… 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
- AUROBINDO (Durham, NC)
- …of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to ... and managing performance issues.Promote employee development and training initiatives.HR Reporting & SystemsMaintain and update HRIS (Human Resources Information… more
- Merck & Co. (Durham, NC)
- …Compliance:-Achieve compliance goals through a risk-based approach (Safety Regulations, Quality Assurance , Risk Management, Deviation Management, Product ... Biologic, and Vaccine Products. Our team works with a "Safety First, Quality Always" mindset.-As the primary point of contact for all dealings between… more
- Pall (Miami, FL)
- …fields with 15 years of progressive Regulatory compliance and / or quality assurance experience.Thorough understanding of ISO 9001 and AS9100 / CAA Part ... the Danaher Business System which makes everything possible.Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets federal/state/international regulations… more
- Mizuho Bank, Ltd. (New York, NY)
- …communication with outside of reporting production team (eg Internal Auditor, Quality Assurance , and FRB) and Change Management Forum. Monitor and ensure ... About the Team: Mizuho Americas Finance - Financial Regulatory Reporting is a team responsible for the preparation of regulatory filings for multiple… more
- AA Inclusion (San Diego, CA)
- About the job Risk Assurance Analyst This position is responsible for assessing internal controls to protect the credit union against loss or regulatory ... reviews, analyzing processes, maintaining access control for application systems, regulatory compliance of the vendor management program, insurance for the… more
- MUFG Bank, Ltd. (Tampa, FL)
- … & Improvement Program (QAIP) position is within the Global Internal Audit function, reporting to a Quality Assurance Director. The position is responsible ... Corporate Functions, Business Line Functions, and Operations. Responsibilities: Execute the quality assurance plan, performing reviews of planning processes,… more
- EY (New York, NY)
- …regulatory mandate. Apply knowledge of SEC rules and regulations over financial reporting . Apply data analytics to deliver high quality audits, providing ... for all. The exceptional EY experience. It's yours to build. Auditor, Assurance (Audit Services) (Manager) (Multiple Positions) (1614642), Ernst & Young US LLP,… more
