- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for end-to-end operational feasibility deliverables at the disease, program, study, country, and site levels. This position is required to work within a team focused ... any specialty vendors.Identify, monitor, analyze and appropriately act on key quality and performance indicators for process oversight/adherence, and measure of… more
- Merck & Co. (Durham, NC)
- …the team finishes the design and construction of the facility, the Operations Manager will play a critical role in supporting the Global Engineering Services team, ... LeadershipEnsure that Shift(s) objectives are achieved while reliably supplying a quality product at a competitive cost consistent with our Company, Regulatory… more
- Merck & Co. (Durham, NC)
- …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...at the shop floor level within the team and site .Provide mentorship and training to team and peers.Liaison effectively… more
- Catalent (St. Petersburg, FL)
- …and to the safety of every patient, consumer and Catalent employee. Compliance Manager is responsible for providing Leadership and Quality Assurance Management ... site . The Department has the responsibility for Quality aspects including but not limited to Quality...Equipment/Facilities, Change Control, etc. The focus of each QA Manager may be dependent upon the needs of the… more
- Merck & Co. (Durham, NC)
- …our Company's Quality Management System.Support and maintain a "Safety First", " Quality Always" environment with participation in Site GEMBAs for Safety and ... and collaborate quality and compliance issues as needed through established site Tiers.Support compliance to Durham Site policies and procedures that promote… more
- Merck & Co. (Durham, NC)
- Job DescriptionOur Quality Assurance group ensures all materials inside our products and the products themselves are manufactured, tested, and distributed in ... alignment with our high standards of quality . Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers, we create an… more
- Catalent (Manassas, VA)
- …for procurement leadership, sourcing and procuring materials, services, and capital for the site . The Procurement Manager will lead site procurement team ... the site and across the company. Leads site -level initiatives for supplier management, supplier quality ...Leads site -level initiatives for supplier management, supplier quality & supplier performance improvement as well as supports… more
- Aequor (Bothell, WA)
- …actions when DI gaps are identified. Periodically report the Data Integrity metrics of the site through the Site Quality Management Review and to the Global ... Description: PURPOSE AND SCOPE OF POSITION: This position reports into the Quality Assurance department and is responsible for assisting with the implementation and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …timeline, budget and objectives set forth by the Study team.The Clinical Study Manager role is primarily a tactical study delivery role, reporting into an Associate ... overall study plan provided by the CRO. Participate in site selection and site qualification with (study...in accordance with DS standards. Act as the project manager of the clinical study team to liaise and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma. Legend Biotech is seeking a Warehouse Operations Manager as part of the Technical Operations team based in Raritan. Role Overview ... The Warehouse Operations Manager will work within Technical Operations and be responsible...within Technical Operations and be responsible for the ongoing site ramp-up, daily operational management, as well as continuous… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …activities in collaboration with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and ... CRO(s) provide timely input and generate documents in a timely manner and with quality (eg communication plan, site monitoring plan, etc.) as per study… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management ... support within at Catalent's St. Petersburg site . The Department has the responsibility for ...and could include all or some aspects of the Quality function.The Product Development QA Manager provides… more
- Catalent (Harman, WV)
- …has an opportunity to make a significant impact on the way that the Harman's site operates. The Manager , Supply Chain - Warehouse will lead a shift consisting ... The Manager , Supply Chain - Warehouse , reporting to...experience to work cross-functionally with support groups to deliver high- quality execution and operational excellence necessary to support a… more
- Eisai, Inc (Exton, PA)
- …Operations, facilities in planning changes to the Pilot Plant and LabsPartner with Site QA in the GMP validation of Lab automation.Document GMP documentation as per ... and manage high-performing staff, address roadblocks and resource or quality issues.Participate in and/or Lead Continuous Service Improvement processes as… more
- Insmed Incorporated (San Diego, CA)
- …maintenance, calibration, and safety checks. Oversees and reviews area weekly and monthly Quality Control and maintain QC database. Set up and validate new assays as ... assigned by the manager .ResponsibilitiesManage and direct work responsibilities for team as well...to meet department key process improvements (KPIs) such as quality initiatives and therapeutic area training (TAT).Oversees daily operations… more
- Aequor (Thousand Oaks, CA)
- …about 1 week a month - multiple short trips. In support of 's Quality Assurance program manages and oversees the operations of a specific area(s) of responsibility ... QA on NPI team) Lead investigations) Lead plant audits, participate in site audits) Approve change-over completion) May perform work of QA Specialist… more
- Lundbeck (Chicago, IL)
- …and psychiatry. Join us on our journey of growth! As an Area Sales Manager (ASM) you will be responsible for leading, developing, and managing a diverse, high ... People Achieves business objectives and sales results by observing Account Manager interactions with target customers, extended treatment team members, ancillary… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for DSI Tech Unit operational activities for developing collaboration site , internal process improvement, developing business process and system integration. ... Unit Team culture. Service as a primary contact with Legal and Quality Assurance regarding records Retention and Training Coordination. Demonstration and successful… 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. (West Lebanon, IN)
- …product based on Quality Assurance record review and approval by QA Manager Performs regular internal audits of NNUSBPI facilities as a lead auditor Works ... About the Department Site New Hampshire, located in West Lebanon, is...to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a… more
