- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and in a manner which meets their expectations Coordinates and collaborates with Quality Assurance function to maintain a COE for deviation management covering ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… 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
- 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
- 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
- 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
- Tris Pharma (Monmouth Junction, NJ)
- …required documentations, in liaison with Product Development (PD)/ Quality Assurance (QA)/ Quality Control (QC)/ Regulatory Affairs, including ... reports. She/he acts as MV lead for assigned projects regularly reporting status/issues to management, conducts laboratory investigations and recommends appropriate… 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
- 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
- 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
- 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
- Mizuho Corporate Bank (New York, NY)
- Regulatory Reporting Quality Assurance , Associate Quality Assurance Unit: The Quality Assurance Unit is responsible for enhancing the ... financial institution in performing financial and/or regulatory reporting , regulatory reporting quality assurance , or internal audit + Knowledge… more
- Mizuho Corporate Bank (New York, NY)
- …standards . Summary: This position is primarily responsible for execution of Mizuho's Regulatory Reporting Quality Assurance Program and providing ... s in performing financial and /or regulatory reporting , regulatory reporting quality assurance or internal audit + knowledge of BASEL… more
