- Tris Pharma (Monmouth Junction, NJ)
- …success. Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , ... standards and objectivesOversee and manage the maintenance and tracking of Quality Systems including, but not limited to Investigations/OOS/OOT/Lab Event,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Quality Systems Lead role as part of the Quality Operations team ... based in Raritan, New Jersey. Role Overview The Quality Systems Lead role is an exempt level position with responsibilities for supporting the quality … more
- Merck & Co. (Durham, NC)
- …of the Quality System Model and relationships across its componentsUnderstands quality systems relevance and importance when developing quality policies, ... grasping pushing and pullingAbility to travel WORKING RELATIONSHIPS: Reports to Quality Manager Interacts with employees within own department Frequent… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. SummarySupport the PVQA quality strategy and quality plan with specialty and the Oncology ... Business Unit globally; promote a quality culture within Global Medical Affairs Quality ...as applicable. Support MA/PV health authority inspections with adequate systems and process support, including facilitation of respective regulatory… more
- Aequor (Thousand Oaks, CA)
- …for signature, and store for compliance. Ideal Capital Projects Sourcing Manager candidate: 5 years hands-on capital construction experience in procurement and ... contracting negotiations and execution. is searching for a Capital Projects Sourcing Manager , who will be responsible for helping execute the sourcing processes… more
- Merck & Co. (Rahway, NJ)
- …challenges and issues to TA Head/CRD Clinical Research Director/CCQM Country Clinical Quality Manager and or CTT Clinical Trial Team-(as appropriate).Identifies ... manager and/or functional vendor and internal management as-needed.Performs Quality control visits as required.Leads local study teams to high performance:… more
- Aequor (Libertyville, IL)
- …incident, problem and change IT operational events (ie ServiceNow). Knowledge of IT systems such as ERP, OSI PI, Client, LIMS, ServiceNow, Celdox and Veeva. ... Knowledge of various IT Systems integration and Agile Methodologies. Knowledge of cGMP, GXP,...pharma/biotech with experience in Automation, Manufacturing, Supply Chain and Quality System disciplines. The candidate needs to understand shop… more
- Merck & Co. (Rahway, NJ)
- …modalities. We are interdependent across our functional areas, Discovery, our Manufacturing Division Quality , and BARDS, to name a few, and with our partners in ... so everyone can bring their whole self to work.Within DSCS, the Digital Program Manager will advance the purpose and aspiration of our Company 's DSCS Digital… more
- Merck & Co. (Durham, NC)
- …the selected individual must become proficient in the use of manufacturing systems and knowledgeable of site procedures to resolve process/equipment issues, minimize ... downtime, and ensure product quality .- This role actively supports, participates, and embraces an inclusive team culture including significant interaction with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting GxP and Non-GxP activities, assuring that these systems ... Validation Lead support for Daiichi Sankyo GxP and Non-GxP computer systems implementations in partnership with Global DX, and QA-CSV/eCompliance team members… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the ... SDTM and collaborating with CROs and other vendors to ensure high quality deliverables to support drug development processes and global submissions as required… more
- Catalent (St. Petersburg, FL)
- …within at Catalent's St. Petersburg site. The Department has the responsibility for Quality aspects related to Quality Systems , Finished Product Batch ... Manager , QA (Product Development)Position SummaryThe Quality ...support to internal, client, and regulatory audits.Engage in monitoring quality systems to maintain awareness and audit/inspection… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …review issues log, develop risk mitigations strategies and ensure all systems are operating well as designed. Ensures compliance with internal controls ... of all Financial Disbursements technology applications and other linked systems . Translates business / functional goals into appropriate Financial Disbursements… more
- BioAgilytix (Durham, NC)
- …variety of project support through all phases of our client services. As a Project Manager I, you will be the glue connecting our internal functions to the actions ... required of an efficient and quality -driven project process. You'll experience a broad range of responsibilities spanning study administration, client… more
- Insmed Incorporated (Bridgewater, NJ)
- …of raw materials, components and services consistent with specified levels of quality , delivery, price and total cost. This position will support the Associate ... data management to ensure accurate and consistent data across the supply chain systems .Implement and maintain data governance practices to enhance data quality … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking a Project Manager , Process Engineer- Consultant as part of the Global MSAT team based in ... to be incorporated with an automation platform that integrates with MES systems in cGMP manufacturing operations. This effort will extend organizationally to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you in? Are you ready to experiment with us? The Position The Manager , NextGen Customer Engagement will support Novo Nordisk's strong commitment to its customers ... responsible for agile execution and support of new capabilities, platforms, and systems within Novo Nordisk in partnership with internal stakeholders and external… more
- Catalent (St. Petersburg, FL)
- …within at Catalent's St. Petersburg site. The Department has the responsibility for Quality aspects related to Quality Systems , Finished Product Batch ... QA Product Manager Position SummaryThe QA Product Manager is responsible for providing Leadership and Quality Assurance Management support… more
- Eisai, Inc (NJ)
- …is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs. ... As the Lead Medical Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the… more
- Novo Nordisk Inc. (Durham, NC)
- …duties and QA presence & process confirmation on shop floor. Relationships Manager , Quality Assurance. Essential Functions Ensures site compliance with ... industry General knowledge of Batch Review Processes (BRP), validation processes and Quality Management Systems (QMS) preferred General knowledge of quality… more
