- Daiichi Sankyo, Inc. (Bernards, NJ)
- …across GxP (GCP/GVL/GCLP/GLP) systems .Lead the development of the global Data Integrity strategy and promote a quality culture throughout the Global ... around rare diseases and immune disorders. SummaryThe Sr. Director, Data Quality and Integrity ( Global ...GxP systems .ResponsibilitiesLeadership and Strategic DirectionThe Sr. Director, Data Quality and Integrity is essential in… more
- Aequor (South San Francisco, CA)
- …required by Roche's clinical trials seamlessly, on-time, and while optimizing cost/ quality . Within Production Enablement, the Global Clinical Materials Manager ... data of drug products and packaging materials in SAP- systems Plan packaging materials in SAP- systems Manage...systems Drive and lead the issue management for global clinical supply concerning the procurement of drug products… more
- Merck & Co. (Rahway, NJ)
- …Supplier Management Systems , etc.Support MDCP sites with new/revised QMS Quality Standards and/or Global Procedures.Perform related duties, as assigned. ... and build QMS capabilities that touch every aspect of our business processes, systems , and data .The Associate Director will collaborate and interact with… more
- 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
- Merck & Co. (Rahway, NJ)
- …Activities: Oversee the Compliance, Remediation, and Support (CRS) team within Global Quality Compliance Support. Provide compliance leadership and direction ... and vaccine drug substances, finished products, and combination products. Oversee quality systems pertaining to health authority inspections, inspection and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …metrics.Implement and manage robust data governance processes to ensure ongoing data quality and security, facilitate or collaborate in regular audits ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...with data governance processes to ensure ongoing data quality and security, supported by regular… 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 ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...and other initiatives. Proactively identifies and manages risks to data quality , data integrity, programming… more
- Aequor (Thousand Oaks, CA)
- …of ICSRs (narratives, coding, expectedness, causality, and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports Act as MSRT product ... the compliance of autolabel tool updates (if applicable) Support and lead Quality Assurance of ICSR medical review (if applicable) Support and lead activities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(eg, CRO); oncology, immunology, or complex disease Strong knowledge of Clinical trial data systems and/or EDC lab management. required- 4+ years combined ... teams, clinical safety and pharmacovigilance, CROs and other vendors to ensure high quality of laboratory data deliverables to support drug development processes… more
- Aequor (Thousand Oaks, CA)
- …actions, procedures revision, Training portfolio, monitoring and revising SAP Mater data Quality Inspection plans, and projects implementation plan. Will ... change requests approved by management. 4. Work within the Information Services and Quality Systems teams to foster good communication throughout the project… more
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