- Insmed Incorporated (NJ)
- …priorities.High technical aptitude for regulatory publishing and document management systems.Detail-oriented with strong focus on data integrity and ... Director, Regulatory Operations, you'll be responsible for the publishing, management , and submission of regulatory documents in accordance with global… 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
- Merck & Co. (Rahway, NJ)
- …quality and our company's standards and communicate project status to management .Act as Development Quality representative for in-house or outsourced ... commitments and maintenance of a cGMP posture within Global Development Quality .Support preparations for regulatory agency inspections.- May accompany … 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
- 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
- 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
- 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)
- …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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and external manufacturing network and Potential involvement with all phases of project management Work with operations and quality groups to maintain products ... rare diseases and immune disorders. We are currently seeking a Technology Management Monoclonal Antibody (mAb) Intern for Summer 2026. This full-time position works… more
- Merck & Co. (Lower Gwynedd, PA)
- …participate in data reviews or process inspections to ensure generation of quality data , maintain metrics associated with quality lab operations, ... vaccines and enable late-stage clinical trials through the generation of timely, high- quality regulated bioanalytical data . -A combination of molecular (eg,… 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
- 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
- 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
- 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
- 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 (San Diego, CA)
- …teams, including:Collaborate with team members in the review and development of Data Management activities including eCRFs, edit checks, report development, and ... requiredStrong medical writing and presentation skillsBasic understanding of biostatistics and data management Ability to read, analyze and interpret common… 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
- Merck & Co. (Rahway, NJ)
- …start-up operations (FLEx) and new capital builds, including automation lifecycle management , data /analytics, and site representation on capital projects.- Some ... acceptable related experience.Required Experience and Skills:- Strong knowledge of cGMP, Quality Systems, Safety, Environmental, data integrity, and validation… 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
