- Aequor (Bothell, WA)
- …experience in pharmaceutical quality operations, quality assurance, quality systems, and/or IT compliance role with at least 3&plus years in a leadership position. ... ability to work cross-functionally and to develop and maintain strong business partner relationships. Demonstrated ability to work effectively with US FDA,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Sr . QC Analyst (Third Shift) as part of the Quality team based in Raritan, ... NJ. Role Overview The Sr . QC Analyst, CAR-T Manufacturing is an exempt level...controlled cGMP cleanroom environment Ensure testing is completed in compliance with all applicable procedures, standards and GMP regulations… more
- Aequor (Thousand Oaks, CA)
- …experience as this role will have buying responsibilities Accountabilities Support business processes related to NA-TO Back Office and process improvements with ... analysis for effective decision making in NA-TO Hub Manage and oversee Compliance related activities Develop strategic and tactical processes that increase the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …operational, reporting and analysis needs - Inclusive of development of processes, control and best business practices around data management. Build organization ... the treatment of multiple myeloma. Legend Biotech is seeking a Master Data Governance Sr . Specialist as part of the Technical Operations team based in Raritan, NJ.… more
- Merck & Co. (Durham, NC)
- …and safe maintenance and repair of equipment using Hazardous Energy Control Procedures (HECPs) Compliance with current good manufacturing procedures(cGMP), safety ... and patients on time, every time, across the globe. The Senior Maintenance Technician is responsible for providing equipment troubleshooting and maintenance… more
- Insmed Incorporated (Bridgewater, NJ)
- …for the successful and timely completion of cross-functional plans. The Sr . Director of Program Management will utilize best-in-class program management support ... Development Plan and associated functional plans. As a leader, the Sr . Director of Program Management will provide cross-functional operational and program… more
- Insmed Incorporated (Bridgewater, NJ)
- …US Compliance reports to the Senior Director, US Compliance .ResponsibilitiesCollaborate with US Compliance Business Partners to support ... risk areas, in particular relating to Commercial practices of a US business .Understanding of compliance internal control concepts and framework.Maintains… more
- Aequor (West Greenwich, RI)
- ARI AR5 ONSITE 100% - PQA Sr . Associate (Nights)- No remote work QA Sr . Associate will be responsible for Quality On the Floor in support of Manufacturing ... hours are 7pm to 7am, with adaptability as required based on the business needs, provides coaching, guidance and direction to Manufacturing, Quality Control … more
- Merck & Co. (Rahway, NJ)
- …all company-sponsored clinical trials, patient safety, high quality data and compliance with company requirements and regulations are delivered and sustained. The ... Sr CCQM Lead supports large to medium size country/cluster...(CCQMs) aiming to achieve the organizational strategic goals and business objectives. -The role is responsible for oversight of… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …improvement, and IT compliance service delivery management across the site. The Senior CSV Analyst ensures that IT solutions are implemented and released to use ... Novo Nordisk-marketed pharmaceutical productsThe Position The purpose of the Senior CSV Analyst (Remote) position is to provide subject...in compliance with relevant regulations and standards facilitating the seamless… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …insights and intelligence to inform decision making & drives digitalization and business solutions to attain NNI goals. Finance and Operations works closely across ... facilities and assuring the integrity and completeness of all business transactions. At Novo Nordisk, you will have the...to maximize your potential with us? The Position The Senior Director, Enterprise Functions Insights Lead is responsible for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategies and implement communication plans to raise stakeholder awareness and drive compliance Ensure department, business unit and enterprise-wide business ... insights and intelligence to inform decision making & drives digitalization and business solutions to attain NNI goals. Finance and Operations works closely across… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Quality Senior Specialist provides expertise in the coordination of resources and equipment pertaining to qualification/validation activities ... supporting the vaccine expansion facility. Primary Responsibilities: The Quality Senior Specialist will be responsible for comprehensive management of all activities… more
- Merck & Co. (Durham, NC)
- …Services, Utilities and Validation. Position Description: GENERAL INFORMATION A Senior Engineer will provide organizational support and technical leadership for ... PQ and requalification activities for multiple pieces of equipment. The Senior Specialist will primarily support vaccine drug manufacturing via Validation program… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Senior Study Manager - Epidemiology OperationsSupport the Lead Epi Scientists by providing overall operational support for study ... or non-interventional research studies (including Post Authorization studies), in compliance with Good Pharmacoepidemiology Practice (GPP) and Standard Operating… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: The Senior Maintenance Technician is responsible for providing equipment troubleshooting and maintenance support for a new ... written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs)… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Senior Specialist, Clinical Literature MonitoringProvides pertinent and timely information on our Company's products and ... Maintains up-to-date awareness in the areas of literature-related copyright compliance , adverse event reporting, and information storage and retrieval systems.-… more
- Catalent (St. Petersburg, FL)
- …functional areas (eg Product Development, Operations, Customer Service, Validation, Quality Control , etc.) to ensure continued compliance for the area/site. ... aspects related to Quality Systems, Finished Product Batch Release, Change Control , Client interface, Lab Investigations, Deviations, Complaints, etc. The focus of… more
- Eisai, Inc (Nutley, NJ)
- …a rchitecture . Functioning as an internal consultancy to Eisai's IT, business leadership, and other stakeholders, th is consultancy provides a cost-effective ... s thought leadership on Eisai's optimized Cloud environment to increase business security, scalability , and enable strategic capabilities for continued growth… more
- Merck & Co. (Rahway, NJ)
- …DescriptionOur company's Information Technology (IT) division partners with colleagues across the business to help serve our patients and customers around the world. ... SAP Global Template asset, delivering enterprise-level capabilities through harmonized business processes and data.-The team is responsible for the operation… more
