- BioAgilytix (Durham, NC)
- …a foundational data governance framework, with hands-on responsibility for data quality , access control, and compliance protocols.Define standards, build ... to meet regulatory requirements, including HIPAA, GxP, GDPR, and FIRPA.Design data quality KPIs and implement initial quality checks independently, ensuring… more
- Merck & Co. (Rahway, NJ)
- …principal component analysis, etc.Develop and implement statistical process control methodologies and data anlaysis to ensure the quality and reliability of ... Job DescriptionThe Principal Scientist, Process Control and Data Analytics will be responsible for leading a...and processes.- It is expected that this role will lead significant investigations or events directly, and mentor and… more
- Novo Nordisk Inc. (Durham, NC)
- …our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate ... us make what matters. The Position Serve as a Lead & Subject Matter Expert (SME) to provide technical...Matter Expert (SME) to provide technical expertise supporting site data and digitalization efforts. Identify and share better practices,… more
- Formation Bio (New York, NY)
- …is ideal for someone passionate about building scalable infrastructure at the intersection of data engineering and applied AI. You'll lead efforts to ingest and ... transform unstructured and structured research, biomedical and clinical data into high- quality , actionable assets that power discovery and decision-making across… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of the Novo Nordisk US Operations (USO) AI Center of Excellence. The individual will lead and manage a team of data scientists, including AI/ML experts and ... evolve the Data Science team to meet internal and market needs. Lead a high-performing, collaborative team environment.Core member of the AI Center of Excellence,… more
- Insmed Incorporated (San Diego, CA)
- …leader managing quality and regulatory compliance related to GCPs, acts as quality lead on the gene therapy clinical development team, and collaborates on ... and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director of Clinical Quality Assurance (CQA)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for defining and ... around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation,… more
- Twist BioScience (South San Francisco, CA)
- …solutions across our biomanufacturing operations. This critical role will drive efficiency, quality , and robust data integrity within a highly automated ... data visualization capabilities to support operational decision-making and quality reviews.Compliance & Validation: Ensure our custom MES solutions comply with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …assessment of available data and determination of knowledge gaps c) translating data into insights with business impact Lead development of assigned market ... strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our… more
- Merck & Co. (North Wales, PA)
- …collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and integrity of ... clinical/scientific execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on the clinical trial team.Leading medical monitoring… more
- Merck & Co. (Rahway, NJ)
- …collaboration with Data Management/Programming. Collaborating cross-functionally to monitor clinical data -to ensure quality , completeness , and integrity of ... execution of clinical protocol(s) . This may include: Serving as the lead clinical scientist on the clinical trial team. Leading medical monitoring team… more
- Merck & Co. (Rahway, NJ)
- …to customers both internal and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings .- Working independently, the ... to: - - Interacts closely with key partner organizations ( as a lead GCS Planning program representative ) such as clinical development, regulatory, quality… more
- Merck & Co. (Durham, NC)
- …and Financial audits, input to QSAT actions, to ensure compliance.Support the Master Data team with general Material Handling Steward tasksDrive safety, quality ... and process enhancements throughout the supply chain - Project Management Lead and sponsor all Supply Chain Logistics initiatives surrounding qualification support… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Novo Nordisk US Operations (USO) AI Center of Excellence (AI CoE). The individual will lead and manage a team of data and AI engineers and developers and is ... safety, managing our supply chain and sampling, supporting technological and data innovation, maintaining our facilities and assuring the integrity and completeness… more
- Merck & Co. (San Francisco, CA)
- …execution of our Company's DSCS Digital Strategy to enable a seamless data infrastructure that drives increased speed, capacity and robustness across organizational ... interdependent across our functional areas, Discovery, our Manufacturing Division Quality , and BARDS, to name a few, and with...with a strong background in the biotech industry to lead digital transformation initiatives. This role will focus on… more
- Insmed Incorporated (San Diego, CA)
- …a Receiving Unit (internal or external QC). May act as a program lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations ... Involves hands-on laboratory work, analytical procedure optimization, troubleshooting, and data analysis and collaboration with all process development teams to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …leverages external expertise in supporting RBQM activities.- Technical: Provides technical guidance in Quality by Design. Lead the team to define Critical to ... Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the vision and strategy for the... Surveillance, targeted source document verification and targeted source data review. Lead the team to develop… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... across clinical, commercial, and enterprise domains. This role involves applying data interpretation and trend forecasting to identify market trends, leading a… more
- Merck & Co. (Rahway, NJ)
- …Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and ... Manufacturing Division / our Research & Development Division ) such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of… more
- Aequor (Houston, TX)
- …on-site 5x/week Responsible for tracking, management, and completion of Supply Chain Quality Records (such as deviations, material recalls, and CAPA) in partnership ... based on identified recurring root cause. Serves as the Quality Record (PR) Subject Matter Expert (SME), Level I,...the compiled final report o Displays ability to gather data from various sources across the site, performance of… more
