- Merck & Co. (North Wales, PA)
- …Biological Sciences, Chemical Biology, Clinical Risk Management , Complaint Management , Cross-Functional Teamwork, Data Quality Assurance, Drug ... Periodic Reports, Pharmaceutical Management , Process Improvement Projects, Process Improvements, Quality Management , Regulatory Affairs Management , … more
- Merck & Co. (Ames, IA)
- …Technical Support and will direct the below aspects of the Supplier Quality Management (SQM) and Animal Health global auditing program:ResponsibilitiesPerform ... oversee both internal and external auditing and Animal Health Supplier Quality Management .- Required QualificationsBachelor's degree (a degree in Engineering,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Operations, Commercial, NNI IT and Telephony, Medical Information, Product Safety, Regulatory , Quality , Legal, Privacy and Finance. External relationships ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...vendor teams on new processes, develops process documentation and quality control documentation of data acquisition and… more
- Formation Bio (New York, NY)
- …identification, evaluation, and management of risks associated with product quality . Build strong relationships with regulatory agencies and other ... regulatory requirements, including GMP, GCP, and ICH guidelines. Expertise in Quality Management Systems (QMS). Extensive knowledge of quality risk… more
- Formation Bio (New York, NY)
- …Structured & Methodical - Brings rigor to semantic modeling, ontology mapping, and data quality management . Collaborative Partner - Works seamlessly across ... files, and unstructured text, ensuring inputs are reliable, well-documented, and metadata-rich. Data Quality & FAIR Principles: Apply FAIR principles to ensure… more
- Insmed Incorporated (NJ)
- …cross-functionally with CMC team, Regulatory , Clinical Operations, and Program Management to drive proactive Quality input into development programs.Provide ... internal teams and external partners. The position is critical in shaping quality strategy, managing risk, and supporting regulatory readiness for complex,… more
- Merck & Co. (Rahway, NJ)
- …Content Management , Content Management Systems (CMS), Cross-Cultural Awareness, Data Management , Data Quality Assessments, Documentation Review, ... and meet business process requirementsDevelop and evaluate metrics as part of a data quality monitoring plan to determine where process improvements or training… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Compliance, Global Safety, and centralized teams (eg, Training and Documentation, Quality , Supplier and Contract Management and Digital Enablement). This ... and hub leadership teams. Works closely patient safety leadership team members in Data Acquisition, Medical Review, and other case management leadership team… more
- Insmed Incorporated (NJ)
- …readiness and inspection management for internal QA, client, and regulatory audits, including regular quality reviews with Patient Services leadership.Drive ... Patient Services Quality & Process is responsible for overseeing the quality monitoring, process management , and continuous improvement efforts that support… more
- Twist BioScience (South San Francisco, CA)
- …with QMS procedures and regulatory requirements.Prepare and maintain quality documentation, including risk management reports, corrective action plans, ... and safety of our genomic products and services by implementing and maintaining a quality management system (QMS) that complies with ISO 13485 and ISO 14971.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …benefit-risk integration to ensure signal, epidemiological data , and regulatory requirement synthesize into a coherent risk management strategy.Represents ... activities and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and… more
- Insmed Incorporated (NJ)
- … data protection standards.Partner with Legal, Compliance, Clinical Operations, Quality and R&D to proactively manage risk across Insmed's technology landscape ... seeking an experienced leader to oversee cybersecurity operations, enterprise risk management , and Computer Systems Validation (CSV) program. This role will manage… more
- Merck & Co. (Rahway, NJ)
- …System & architecture governance Ensure compliance with enterprise architecture, security, data governance, safety and regulatory requirements; manage risks from ... data for prioritization. Experience with safety, security and regulatory considerations in industrial environments. Desirable Prior experience deploying MES,… more
- BioAgilytix (San Diego, CA)
- …build proficiency in MS Excel, MS Word, LIS, LIMS and Quality Management softwarePreferred Credentials:Experience with shipping and receiving ... patients who need them.In this San Diego onsite role, the Sample Management Technician is responsible for GxP-compliant processing of incoming samples and reference… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and implementing study/program-specific quality plans for proactive quality management .Collaborate with the audit function, Data Management teams, MA ... programs.Partner with Medical Affairs to facilitate the implementation of a risk-based quality management process fully embedded through trial design, execution… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Affairs, etc.); advanced degree preferred 7+ years of experience in documentation management , quality assurance, or regulatory compliance within the ... The ideal candidate will have a strong background in documentation management , process oversight, and regulatory compliance within the pharmaceutical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …vendors) and external vendors/contractors Ensure seamless operations and timely delivery of safety data Risk Management Act as the primary point of escalation ... internal stakeholders to proactively identify and mitigate potential issues Compliance & Quality Assurance Partner with NNI Patient Safety Management to ensure… more
- Cipla (Hauppauge, NY)
- …integrity, compliance, and performance of IT systems, contributing directly to product quality and regulatory adherence. You will primarily be responsible for ... the batch record review process, particularly in relation to audit trail management and data integrity. Ensure completion of individual training assigned… more
- Genmab (NJ)
- …with CDISC and regulatory submission requirements, reviews study submission data packages to ensure quality and integrity Directly supports knowledge ... on data standards, reporting and analysis standards, change control management and related tools/applications Creates quality control processes, metrics and… more
- Merck & Co. (North Wales, PA)
- …Provide oversight and quality management of submission data standard deliverables for world-wide regulatory application submissions of drug ... convert complex ideas and information into simple readable form.Solid project management skills.Familiarity with clinical data management concepts.Strategic… more
