- 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
- Catalent (St. Petersburg, FL)
- …responsibility for Quality aspects including but not limited to Quality Systems , Finished Product Batch Release, Training, Internal/External Audits, ... safety of every patient, consumer and Catalent employee. Compliance Manager is responsible for providing Leadership and Quality...of bachelor's degree, a minimum of 5 years of Quality or IT role supporting GxP systems … 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
- 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
- Aequor (New Brunswick, NJ)
- …a basic understanding of business specific organizations functions and support systems (manufacturing, packaging, artwork, regulatory, marketing, quality , and ... onsite required for training and once done min 50% required onsite as per manager .Job Summary:The primary function of this role is to lead / participate in a… more
- Merck & Co. (Durham, NC)
- …investigations, corrective and preventative actions, reviews and approvals through current Quality Systems (eg, CLUE and SAP).Escalate and collaborate ... including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories.The Quality Assurance Senior Specialist will… 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...Support the treatment and on time closure of deviations, Quality investigations and CAPA's related to operational activities. Ensure… more
- Aequor (Bothell, WA)
- …(8) or more years of relevant work experience in pharmaceutical quality operations, quality assurance, quality systems , and/or IT compliance role with at ... AND SCOPE OF POSITION: This position reports into the Quality Assurance department and is responsible for assisting with...and GAMP standards for DI and validation of automated systems is required. Experience with QA oversight of e-… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …expectations for products. The incumbent is responsible to adhere and maintain Quality Management System and GMP Compliance Programs to assure product quality ... and supporting complaint and recall programs, . This position interacts with Quality Assurance (QA) sub-functional and cross-functional teams, as well as Contract… 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 ... in accordance with DS standards. Act as the project manager of the clinical study team to liaise and...functional integration and delivery of items (eCRF, EDC, IXRS, Quality Oversight Plan etc) per the study plan. Oversee… 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
- Novo Nordisk Inc. (Durham, NC)
- …by developing & executing tactical & strategic plans. Relationships Senior Manager , Facilities, Utilities, Systems , Equipment (FUSE). Essential Functions ... our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate… more
- Eisai, Inc (Exton, PA)
- …Lab PCs and process and execution for lab workflow on device attached systems .Partner with Lab Operations, facilities in planning changes to the Pilot Plant and ... and manage high-performing staff, address roadblocks and resource or quality issues.Participate in and/or Lead Continuous Service Improvement processes as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Strategic Sourcing activities. This position will ensure the acquisition of high- quality goods/services at the best possible prices by negotiating and monitoring ... and maximizes opportunities for realizing cost savings without sacrificing the quality , service and reliability expected of our suppliers Understands broad… 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
- 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)
- …any specialty vendors.Identify, monitor, analyze and appropriately act on key quality and performance indicators for process oversight/adherence, and measure of ... Daiichi Sankyo's existing feasibility related portfolio of platforms, tools and systems . Qualifications: Successful candidates will be able to meet the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …simultaneously Perform tasks in a manner consistent with the safety policies, quality systems , and cGMP requirements. Drive continuous improvement Other duties ... of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview The QA… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …consistency and quality of data across key Daiichi Sankyo regulatory systems . This includes defining regulatory data standards, data quality rules and ... areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process… more
