- Legend Biotech USA, Inc. (Raritan, NJ)
- …assigned work, direction, coaching and developing capabilitiesKey Responsibilities Manage the global Compliance leads to ensure harmonization and alignment ... the treatment of multiple myeloma.Legend Biotech is seeking Head of Compliance as part of the Global Quality team based in Raritan, NJ. Role OverviewThe Head of… more
- Merck & Co. (Omaha, NE)
- …Chain Director, the Specialist will support the development and implementation of global trade compliance policies, procedures, and related training. The ... needed. This role is a key part of the team driving global trade compliance policies and procedures within our Company Animal Health. Additionally, the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ComplianceMaintain full accountability for the integrity, transparency, and governance of global forecasts, ensuring compliance with internal policies and ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Eisai, Inc (Nutley, NJ)
- …along with a proven track record in inspection-facing roles and global regulatory compliance .Essential Functions Clinical Outsourcing Designs and executes ... The Senior Director of Clinical Outsourcing provides strategic leadership for global outsourcing and vendor management activities within clinical development. This… more
- Merck & Co. (Durham, NC)
- …Computer Literacy, Digital Literacy, Driving Continuous Improvement, Freeze Drying, Global Manufacturing, GMP Compliance , GMP Operations, Good Manufacturing ... our right to produce. We work in local plants connected to our global manufacturing network supplying the highest quality of raw materials, intermediates, and… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Global Packaging Procurement Director is responsible to lead the Packaging Center of Excellence (COE) organization. The scope for this role ... category management for the packaging category led by the global COE's, either directly (for local managed categories) or...scope of services under the supplier are executed in compliance with the contract and in a timely manner.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... and communicating periodically metrics to DSI QA involved functions and DS Global QA organization. Demonstrate engagement with GMP QA quality managements, Pharma… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Control reviewer for new and revised procedures and documents to ensure compliance with global and site procedures.Support Document Management system users ... Legend Biotech is a global biotechnology company dedicated to treating, and one...in a sterile GMP environment. This role will ensure compliance within the document management system, document storage and… more
- Formation Bio (New York, NY)
- …improve efficiency, compliance , and overall quality assurance practices.Responsibilities Ensure compliance with global regulations (eg, FDA, EMA, ICH) and ... storage, and distribution of Formation Bio's portfolio are executed in compliance with regulatory requirements, industry standards, and company procedures. This role… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... research areas centered around rare diseases and immune disorders. SummaryThe Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the Senior… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... centered around rare diseases and immune disorders. SummaryThe Executive Director, Global Oncology Medical Affairs, External Scientific Collaboration role will be… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director, Technical Operations within Global Clinical Supply (GCS) is responsible for technical leadership in support of GCS global facilities ... equipment-based challenges when required.- The technical lead may also manage global infrastructure projects to establish, upgrade, and improve the GCS packaging,… more
- Eisai, Inc (Philadelphia, PA)
- …If this is your profile, we want to hear from you. The Director, Global Labeling is responsible for the leadership and oversight of the Labeling function within ... Global Regulatory Services and Operations (GRSO). This position will...and approval.Ensure consistency of labeling across product lines and compliance with Eisai policies and procedures and applicable regulatory… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to collaboratively work within identified sub-teams to develop best practices for global initiatives in validation, quality compliance and material/ raw material ... ranging from control strategies to PVP and PPQ templatesSupport global initiatives related to quality/ compliance /validation (APS benchmarking, Validation… more
- Formation Bio (New York, NY)
- …multiple clinical programs across various therapeutic areas and phases (I-IV), ensuring compliance with global regulations, delivering on timelines and budgets, ... years in a leadership capacity. Proven track record in managing complex global trials across multiple phases (I-IV) and therapeutic areas. Experience working within… more
- Insmed Incorporated (NJ)
- …process for Inspection Readiness.Contributes to the development and review of regional/ global policies and procedures. Ensure compliance with all ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...processes and set direction in related areas such as compliance , CRO management, risk management, etc.Ability to prioritize and… more
- Insmed Incorporated (NJ)
- …patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare ... as the IT System Owner for the Learning Management System and compliance IT systems, which includes supporting GxP-regulated applications, while also functioning as… more
- Merck & Co. (Rahway, NJ)
- …to device-drug integration. Partner with Quality and Regulatory teams to ensure compliance with applicable global regulations. Leverage data analytics and key ... identifying process inefficiencies using operational excellence tools and ensuring alignment with global regulatory requirements (eg, FDA 21 CFR Part 820, ISO 13485,… more
- Eisai, Inc (Nutley, NJ)
- …projects, omnichannel activities, targeted advertising, etc.) and daily business activities in compliance with state, federal and global privacy laws. Draft, ... Advise on cross-border data transfers (eg, clinical data) and collaborate with global privacy counterparts to ensure compliance with international frameworks… more
- Repligen (Waltham, MA)
- OverviewMake a global impact-join Repligen.We're united by a mission to inspire advances in bioprocessing as a preferred partner in the production of biologic drugs ... & ITGC ComplianceWe are seeking an experienced IT Manager, SOX & ITGC Compliance to lead the design, implementation, and ongoing effectiveness of internal controls… more
