- Genmab (NJ)
- …Then we would love to have you join us!The RoleThe Associate Director, External Data Quality Management, is a strategic leadership role within Clinical Data ... strategic guidance on data workflows and compliance across the clinical portfolio. Data Quality and ReconciliationOversee and guide the execution of external … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of QA across GxP (GCP/GVL/GCLP/GLP) systems. Lead the development of the global Data Integrity strategy and promote a quality culture throughout the Global RD ... other research areas centered around rare diseases and immune disorders. SummaryThe Sr. Director, Data Quality and Integrity (Global R&D & PV QA) ensures high… more
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of external data -- acceptance, storage, and delivery activities to ensure complete, high- quality data is available for use by clinical study teams in a ... to manage and coach people, and the capability to lead multiple projects concurrently are crucial for this role....and other initiatives. Proactively identifies and manages risks to data quality , data integrity, programming… more
- Formation Bio (NC)
- …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
- Aequor (Swiftwater, MN)
- …The Lab Information Management System [LIMS] Business Administrator is essential to Quality Operations at the Swiftwater site for supporting the maintenance and ... LIMS system. Maintenance support will include supporting Business Administrators in, updating master data for new and existing products, updating master data for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …teams, clinical safety and pharmacovigilance, CROs and other vendors to ensure high quality of laboratory data deliverables to support drug development processes ... laboratory data processes, technology, and standards. This position ensures quality delivery of laboratory data for clinical trials, clinical development,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …database release, data review and cleaning, database lock), to ensure data quality /integrity and regulatory complianceEnsures that Data Management Plans ... global data management strategy across regions and across studies/programs. Lead DM resource model internalization for both strategy and implementation in terms… 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
- Merck & Co. (Rahway, NJ)
- …Position Overview - Basic Functions & Responsibility As a member of the Device Quality & Regulatory QMS group, the Associate Director will participate in and/or ... lead various initiatives in support of our QMS Purchasing...touch every aspect of our business processes, systems, and data .The Associate Director will collaborate and interact with cross-function… more
- Aequor (Thousand Oaks, CA)
- …actions, procedures revision, Training portfolio, monitoring and revising SAP Mater data Quality Inspection plans, and projects implementation plan. Will ... possible remote role Summary: Under general direction, functions as the Specialist Quality Control working at the Corporate QC Center. Description: Job Details:… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… more
- Eisai, Inc (Nutley, NJ)
- …Software Developer Validation Quality Professional will work closely with the quality assurance clinical systems lead to deliver on internal validation ... Quality Professional l will work closely with the quality assurance clinical systems lead to deliver...Support computer system audits for review of SDLC and data integrity controls. Review CAPA and verification of CAPAs… more
- Tris Pharma (Monmouth Junction, NJ)
- …has an immediate opening for a SR. Manager or Manager, Quality Management Systems (QMS). Title commensurate with experience.Summary:This position supports, oversees ... and manages the Quality Assurance (QA) Investigations and Product Quality ...(OOS/OOT/Lab Event) and manufacturing investigations and CAPAs/CPIs Performs in-depth data analysis to identify compliance concerns, root causes and… more
- Aequor (Swiftwater, MN)
- Shift: 1st Work Schedule: 8AM - 4PM EST Mon-Fri Quality Control Technician II (Manufacturing/ Quality ) 1st Shift: QC Instrument Support (QCIS) Description This ... position will support the lifecycle management of instrumentation within the Quality Control department at the Swiftwater, PA location while strictly adhering to… 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 ... QA presence & process confirmation on shop floor & improvement of Quality processes. Relationships Reports to Manager, QA. Essential Functions Ensure plant systems… 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
- 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
- Merck & Co. (Boston, MA)
- …leading squads and maintaining product lifecycle Manage scientific applications and lead squads to build user-friendly scientific data and technology ... in R&D IT brings together product management, engineering, and data science expertise. We enable data , technology...the RaDS Product organization. The position will report to the- Lead of the Disease Biology and PharmTox Product Line.… more
