- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking a QA Laboratory Compliance Manager as part of the Quality team based in Raritan, NJ. Role OverviewThe ... QA Laboratory Compliance Manager role is an exempt level position with responsibilities...oversight over the compliance program for the site Quality Control laboratories in support of both clinical and commercial… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Accounting at Novo Nordisk Inc. As part of the NNI Finance team, the manager will business partner with budget controllers (FP&A) and other key stakeholders across ... as needed Responsible for the execution and periodic updates of accounting-related control activities Partners with the financial compliance group to ensure an… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Manager as part of the Quality team based in Raritan, NJ. Role ... OverviewThe Quality Compliance Manager is responsible for regulatory compliance supporting the production...team meetings, mentor site users for audit process, and control access to any systems used to support audits/inspections.Provide… more
- Novo Nordisk Inc. (Virginia, WA)
- …with key stakeholders. Future-looking leader with superior ability to lead through change . Relationships Internally, the Educator Manager (EM) reports to a ... regulatory/legal mandates Review and audit direct reports' expense reports. Exercise prudent control of field expenses Ensure timely and accurate submission of other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in support of early phase to late-stage clinical studies. Accountable for the control and reporting of GEMRAD approved budgets. On a monthly basis prepare actuals ... communicates key findings and presents recommendations to senior management.Special Projects/ Change Management - Create and maintain up-to-date process documentation… more
- Fidelity Investments (Boston, MA)
- Job Description:Senior Manager - Global Financial Controls Center of ExcellenceThe Global Financial Controls Center of Excellence (GFC-CoE) is an enterprise-wide ... advisory services for select strategic initiatives and modernization efforts.The Senior Manager role will deliver significant value to the business by leading… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …under general supervision; follows established procedures with some latitude to change work processes and workflow. Automation Engineer will perform PLC Programming ... will be commisserate with experience. Relationships Reports to: Automation Manager Essential Functions Responsible for assisting with the design, implementation,… more
- Aequor (Thousand Oaks, CA)
- …own the execution of the implementation plan in terms of project management and change control execution. This role will apply project management and operational ... management of products. SPECIFIC RESPONSABILITIES INCLUDE BUT ARE NOT LIMITED TO: Manage change control timelines with input from Variation Leads and/or Regional… more
- Novo Nordisk Inc. (Durham, NC)
- …experience required LEAN manufacturing experience and training required General knowledge of change control systems and Quality Management Systems (QMS) required ... Process Professional and as a mentor/coach for junior team members. Ensure that control charts are established and maintained based on the product strategy. Ensure… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …including standard precautions and hazardous and biohazardous chemical handling.Knowledge of change control practices for major equipment, important systems, ... and computerized systems.Knowledge of quality systems including exception management, change control , document control .Knowledge of operating… more
- Merck & Co. (Durham, NC)
- …uring equipment, facilities and utilities. Preferred Experience and Skills: Prior Change Control and Deviations Management experience GMP quality experience ... biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories.The Senior Quality Assurance Specialist will support this… more
- Novo Nordisk Inc. (Durham, NC)
- …operation of identified local manufacturing applications. Improve reliability of process control systems to meet current & projected customer, business & regulatory ... following activities: People Focus, Equipment Focus & Standards "Gatekeeper". Relationships Manager , Technical Support - OFP Essential Functions Work primarily with… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Support engineering with coordination, processing, tracking and documentation of Deviations (DVs), Change Requests (CRs), document change control (DCC's) ... role Monday-Friday. Relationships Reports to: Manufacturing Engineering & Validation Manager Number of subordinates with direct/indirect referral: none Essential… more
- Merck & Co. (Durham, NC)
- …investigation experience Preferred Experience and Skills: Project management, including change control and equipment qualificationSAP experience related to ... by policies, procedures and business plan; receives limited guidance from manager .Provides planning and scheduling guidance to mechanics, technicians and colleagues… more
- Novo Nordisk Inc. (Durham, NC)
- …explorative statistics, multivariate statistics, acceptance sampling and statistical process control . Partner with senior statistician team members to develop & ... teach courses and workshops in statistical topics. Relationships Senior Manager . Essential Functions Provide statistical support and probability data as it relates… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …process instructions for manufacturing equipment in accordance with site Change Control and Validation requirementsPerform investigation of manufacturing ... in SolidWorks, MS Project, and MS Office products desiredProcess Control and Instrumentation experience a plusProject Management experience in food,… more
- Genmab (Plainsboro, NJ)
- …futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment ... (i) the design and implementation of privacy specific technical engineering and control strategies based on Genmab's data protection, privacy and data ethics… more
- Merck & Co. (Durham, NC)
- …investigation and CAPA experience, Batch Record Review, Validation IQ, OQ, PQ, Change Control .Has in-depth knowledge of cGMPs and domestic and international ... ability to meet performance objectives.Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with… more
- Merck & Co. (Durham, NC)
- …including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories. - The Quality Assurance Specialist will support this ... to meet performance objectives. Consults on an as-needed basis with next level manager on more complex decisions. Executes critical site review and review of… more
- Novo Nordisk Inc. (Philadelphia, PA)
- …disease achieve greater health outcomes. If you are passionate about being a force for change , not afraid to take risks and challenge the status quo, and are looking ... health. Internally, the OCS reports to the District Business Manager of the specific sales territory. The OCS also...the opportunity to call on targeted customers Exercise prudent control over samples and other company property in accordance… more
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