- Legend Biotech USA, Inc. (Raritan, NJ)
- …the candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance , clinical quality , ... QA Shop Floor Supervisor as part of the Quality Operations team based in Raritan, New Jersey. Role...such as SOPs, work instructions.Develop positive relationship with the QA team, Quality Control, Information Technology, Maintenance,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …arise, in collaboration with other QA line functions (Audits and Compliance , QMS, PV/MA Quality ).Participate and support lessons learned activities from ... that the organization is in a perpetual state of compliance as follows:Support the Global Quality Lead(s)...the delivery and execution of non-project initiatives within R&D Quality and Global RD/PV QA by collaborating… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Executive Administrative Assistant to provide comprehensive support to leaders and members of GMP Quality Assurance team and will serve as the primary point of ... Monitor and manage payment schedules, approvals, and reimbursements. Ensure compliance with organizational policies and procedures related to agreements and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the promise of an 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 ...requiredA minimum of six (6) years of experience in Quality Assurance / Quality Systems or… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Working in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance , or manufacturing compliance .Expertise in GMP ... successfully implement and maintain tools, standards, policies and procedures in compliance .Handling day-to-day activities for BAS, EMS and other automation and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …timely remediation.SOP Authorship and Review Maintain a close working relationship with Quality Assurance and participate in the Company Global SOP Committee. ... year' experience in pharmaceutical or biotechnology development functions or clinical quality assurance required Experience Qualifications Experience:10 or More… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance , or manufacturing compliance .Thorough knowledge and ... project execution and management, vendor management, data life cycle management, Quality events, remediation and improvement efforts of computerized systems for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …is preferable that the candidate have 2 years + of experience working in Quality Assurance . Previous cell therapy experience is a plusKnowledge of cGMP ... efforts, site escalations, and quality projects.Key Responsibilities Provide quality and compliance input for identified continuous improvement efforts… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …on preventing failures (increasing availability), but also on increasing EHS & QUALITY compliance or reducing costs (without reducing availability). He/she ... failures (increasing availability), but also on increasing EHS & QUALITY compliance or reducing costs (without reducing...proposals to reach a solution with relevant stakeholders (eg QA , C&Q, Operations, ). You will develop root cause… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance , Medical Affairs, Translational Research, Research, ... systems and architecture. Advocates for good architecture and design practices and compliance in all relevant areas. Assists IT and business leadership in… more
- Merck & Co. (Rahway, NJ)
- …to deliver objectives.-Take responsibility for any clinical audits, working closely with the Quality Assurance ( QA ) group-and the Good Clinical Practice ... compliant, collaborative, and innovation-focused work environment.-Builds a culture of quality and compliance through training, oversight, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …SDTM and collaborating with CROs and other vendors to ensure high quality deliverables to support drug development processes and global submissions as required ... required to support Data Management and Biostatistics, as necessary.Perform validation and QC/ QA of CDISC, SDTM domain output in accordance with SOPs, SOIs, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Qualifications Bachelor's degree or equivalent experience required 8+ years of operations, quality assurance , call center, compliance , project management, ... Director. Interacts with colleagues within Patient Support Programs, Patient Safety, Quality , NNI IT and Telephony, Medical Information, Compliance , Regulatory,… more
- Genmab (Plainsboro, NJ)
- …areas for improvement and drive process enhancements.Align GCDS efforts with Quality Assurance , Clinical Strategy, and other stakeholders.Address drug supply ... be an initiative driven and proactive player with responsibility to deliver high quality trial supplies on time from an planning perspective. Changes are a natural… more
- Merck & Co. (Rahway, NJ)
- …sound understanding of related fields (eg, manufacturing, process development, analytical, quality assurance ) and the ability to be creative and ... regulatory activities for Devices and Drug-Device Combinations (DDDC), ensuring compliance with domestic and international regulations and guidance. This role… more
- Genmab (Plainsboro, NJ)
- …briefings; agency request responses) as applicable, in markets within scope Drive compliance by providing guidance and advice to cross-functional teams on market ... requirements as applicable Liaise and collaborate with internal teams (eg QA , manufacturing), external teams (eg contract manufacturing, CRO, affiliates), and… more
- Merck & Co. (Rahway, NJ)
- …Clinical Safety , including training process standards and strategies to ensure optimal quality and compliance in Global Regulatory Affairs and Clinical Safety ... and collaborates with internal and external functions such as our company's QA , GCD Standards, and Learning & Development. This collaboration is essential in… more
- Citigroup (New York, NY)
- …as Business Execution for our Technology, and Foundational Services functions. The T&BE Quality Assurance ( QA ) function sits within T&BE COO organization ... across T&BE organization and oversees Controls, Analytics and Decision Management, Quality Assurance , Regulatory Management, Data and Transformation for… more
- Compass Group, North America (New York, NY)
- …but the start of a career where you can flourish. Job Summary The Director of Quality Assurance will lead the development and execution of comprehensive QA ... the creation, execution, and maintenance of food safety and quality assurance programs across all Kirkland &...Strong knowledge of HACCP program development, FSMA, and regulatory compliance . + Experience managing multi-unit QA programs,… more
- Taiho Oncology (Princeton, NJ)
- Sr. Manager, Quality Assurance GMP Princeton, NJ, USA Req #428 Wednesday, January 22, 2025 Looking for a chance to make a meaningful difference in the oncology ... and contribute to the continuous building of a unified Quality Assurance (GMP) function in a dynamic,...effectively interact with internal and external parties to ensure quality compliance needs are met in a… more
