- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …across a global manufacturing network.Familiarity with digital manufacturing systems (eg, MES, SCADA) and data analytics platforms.#Li-JK2#Li-HybridThe ... (FDA, EMA) on manufacturing innovation topics.Foster a culture of innovation, data -driven decision-making, and proactive problem-solving across Global MSAT.Stay… more
- Merck & Co. (Rahway, NJ)
- …PurposeThe Director of GMP Compliance will report to the head of the Global Quality Compliance Support organization.- The responsibility of this position crosses ... documents meet major health authority GMP requirements-Provide consulting and research services to global QMS topic owners and site quality experts to assess the… 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
- 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
- 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
- Eisai, Inc (Nutley, NJ)
- …capabilities to independently carry out routine, complex and for-cause audits Knowledge of data integrity controls and systems quality for clinical area ... If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for… 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
- Novo Nordisk Inc. (West Lebanon, IN)
- …take on multi-disciplined projects, with minimal supervision Functional understanding/application of quality systems with the ability to manage Change Controls ... Nordisk's life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well… 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 ... other enterprise systems (eg, ERP, LIMS, QMS), and ensure compliant data flow across the biomanufacturing ecosystem. Data Integrity & Reporting: Architect and… more
- Merck & Co. (Rahway, NJ)
- …system and passive data governance reports to ensure high quality data and timely and complete synchronization between systems . Acts to resolve all ... Job DescriptionPosition Overview Within the Global Business Solutions (GBS) organization, the SAP Sr....are not limited to, the following: Strong knowledge of Systems Applications and Products in Data Processing,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … systems across the organization. This position ensures that all global systems , electronic records, validation processes, and regulated applications meet ... driving the methodology, approach, and best practices for GxP systems while ensuring alignment with the Global ...and advocate for scalable, compliant architecture and design.Collaborate with global quality , IT, and business leaders to… more
- Merck & Co. (Durham, NC)
- …technology systems , and develops strategies to optimize and ensure quality and stability of automation systems through future expansion, replacement, ... Job DescriptionOur company is expanding its global recombinant human papillomavirus (HPV) vaccine production network by investing $650 million and have added a… more
- Merck & Co. (Durham, NC)
- …technology systems , and develops strategies to optimize and ensure quality and stability of automation systems through future expansion, replacement, ... Data Management, Emerson DeltaV, GMP Environments, Problem Management, Quality Management-Preferred Skills:Job Posting End Date:06/20/2025 *A job posting is… more
- Merck & Co. (Durham, NC)
- …training to mechanics and other maintenance personnel.Interface with safety, production, and quality groups to ensure facility operations and systems comply with ... (both minor and major), with responsibility to interface with Operations, Global Vaccine Technology (GVTE), Automation, and Quality approvers.-Perform a… more
- AUROBINDO (Durham, NC)
- …data protection strategies.Monitor system performance, availability, and security.Update systems with patches and security updates as necessary.Monitor network ... Pharma USA, Inc. is committed to delivering a broad portfolio of quality , affordable generic pharmaceuticals to pharmacists and patients. Aurobindo Pharma USA, Inc.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for purpose and compliant with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality , CSPV, Clinical ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...to track process compliance, performance and adherenceWork with the data / systems SMEs to define reporting needs to… more
- Merck & Co. (North Wales, PA)
- …Experience: Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise ... drugs and vaccines for the benefit of patients and global human health. - Responsibilities : This position supports...project plans are executed efficiently with timely and high quality deliverables. - For assigned projects the position serves… more
