- Insmed Incorporated (San Diego, CA)
- …Millennials™, and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance , the Director of Clinical Quality ... for potential use and provides direction, guidance and strategy for company Quality Assurance .Full understanding of and practical experience establishing and… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is ... in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of...delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and… 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
- Merck & Co. (North Wales, PA)
- …management conceptsExperience in CDISC and ADaM standardsDemonstrated success in the assurance of deliverable quality and process compliance.Strategic thinking - ... Job DescriptionIn BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our...project plans are executed efficiently with timely and high quality deliverables.For assigned projects the position serves as the… more
- Eisai, Inc (Raleigh, NC)
- …Eisai Raleigh facility. This position is responsible for executing core quality assurance functions, supporting regulatory inspections, and collaborating with ... in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of...and/or Biologics is a plus). Demonstrated experience across applicable quality assurance functions in a GMP setting… more
- Merck & Co. (Durham, NC)
- …Manufacturing Processes, Operations Support, Pharmaceutical Production, Pharmaceutical Quality Assurance , Production Operations, Production Scheduling, ... make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant… 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 ... trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of… more
- Merck & Co. (Rahway, NJ)
- …Mechanical Apptitude, Pharmaceutical Development, Pharmaceutical Manufacturing, Pharmaceutical Quality Assurance , Process Technologies, Production Efficiencies, ... GMP (Good Manufacturing Practices) manufacturing facility in the Small Molecule Process Research and Development (SM PR&D) organization. The SSO pilot plant enables… more
- Merck & Co. (Rahway, NJ)
- …IT Business Solutions, Management Process, Management System Development, Problem Management, Quality Assurance (QA), Resource Planning, Service Delivery, SLA ... and forecasting.Communicate IT strategy and portfolio to key stakeholders in our Research & Development Division and IT.- Encourage a digital mindset and adoption… more
- Merck & Co. (Rahway, NJ)
- …members, fostering a collaborative and innovative team environment.Regulatory Compliance and Quality Assurance :Ensure that all activities are conducted with the ... launch in alignment with the company's business goals, and quality and regulatory compliance.-Essential Duties and Responsibilities:Strategic Leadership and Project… more
- Merck & Co. (Upper Gwynedd, PA)
- …related pharmaceutical operations (eg, manufacturing, formulation and process development, analytical, quality assurance , n ovel modality and technologies such ... least five (5) years of relevant experience, including biological/pharmaceutical research ; manufacturing, testing, or regulatory CMC; or related fields.-The… 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 ... Job DescriptionIn BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our...project plans are executed efficiently with timely and high quality deliverables. - For assigned projects the position serves… more
- Eisai, Inc (Exton, PA)
- …will collaborate effectively with other Development groups as well as with Facilities, Quality Assurance , Quality Control, Regulatory, and CMC Program ... Interact cross-functionally with Support Services, Facilities, Biologics Process Development, Quality Assurance , Quality Control, Validation, and… more
- Insmed Incorporated (San Diego, CA)
- …strategies.Facilitate collaboration with both internal and external drug substance analytical, quality control, quality assurance , and manufacturing ... team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Confirm final profile and submit in Zycus for SAP creation.As relevant, liaise with the Quality Assurance group to obtain QA risk rating and audit status for RDP ... up-to-date evaluations. Review and update questions and pending statuses with the Quality Assurance group on a regular basis.Qualifications Successful candidates… 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
- Tris Pharma (Monmouth Junction, NJ)
- …contract negotiations, supplier relationship management, procurement systems functionality/workflows and assurance of compliance with GxP and other company and ... across organization to ensure continuity of supply while optimizing cost, quality and delivery for internal and external stakeholder satisfactionCollaborates cross… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This role collaborates with cross-functional ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryThe Regulated… more
- Guidehouse (Bethesda, MD)
- …NHLBI and NIH Clinical Center. Manage clinical research data and providing data quality assurance . What You Will Need: Bachelor's Degree in Nursing and SIX ... and/or hematology/oncology. Manage clinical research data and providing data quality assurance . What Would Be Nice To Have: Preferred experience working in… more
- University of Maryland Medical System (Baltimore, MD)
- …served, and the profession of nursing. Researcher. Supports and participates in research and quality assurance activities. Creates innovative programs ... the professional development of staff. Supports and participates actively in ongoing research and quality improvement activities. This leadership role assumes… more
