- Merck & Co. (North Wales, PA)
- …requirements are addressed via fit-for-purpose quality management oversight.Evaluate external partner Quality and compliance robustness and identify Quality ... of new modalities products manufactured in the network and at external partner sites. The leader will interact with our cross-divisional/functional teams from… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical Operations team based ... in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide strategic direction and leadership for the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and quality tasks performed by suppliers and business partners to ensure compliance with SDEA requirements. Relationships This position reports to the Director, Case ... Review & Compliance Reporting within Patient Safety. This position works closely...inspection readiness Develops and maintains company (safety) SOPs Business partner liaison: Liaises with suppliers and corporate partners on… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of multiple myeloma. Legend Biotech is seeking Operations Manager- Investigations and Compliance as part of the Technical Operations team based in Raritan, NJ. ... individual will be responsible for overseeing Operations related Investigations and general Compliance , as it relates to personalized cell therapy to support process… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …contractors meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with global Quality ... validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service Provider Outsourcing).… more
- Eisai, Inc (Nutley, NJ)
- …Director, Omnichannel Marketing (HCP and Patient). The associate director will also partner closely with key internal partners to deliver omnichannel and media ... and strategies across target audiences as well as ensure regulatory/legal and compliance requirements are met.This role requires strong marketing and media skillset… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …resourcing to respond to labeling-related questions during Health Authority inspections and partner PV audits. Review and ensure compliance with PV Agreements ... knowledge of scientific, regulatory, and business perspectives to ensure compliance with evolving global regulatory requirements and with company objectives.… more
- Aequor (NV)
- …Import/Export 's Global Trade Office is an organization within the Trade Compliance function. Centralized under Global Supply Chain, this team is accountable for ... Members of the Global Trade Office provide program oversight for trade compliance , establish controls and global standards for regional execution and are experts… more
- Eisai, Inc (Nutley, NJ)
- …profile, we want to hear from you. Job Summary Oversees and assures compliance with standard operating procedures, compliance with regulatory standards and ... area responsibility. Interacts with staff at other Eisai and co-marketing partner Safety offices, healthcare professionals and consumers to obtain and follow-up… more
- Eisai, Inc (Nutley, NJ)
- …demonstrating performance improvements and ROI impacts. Launch planning and execution : Partner with cross functional leaders to create and deliver training that ... commercial field teams to successfully launch new products. Needs Analysis: Partner with Commercial Executives and other stakeholders to determine their strategic… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …improvements within the change control system. Recognize and act on potential compliance issues and opportunities for process changes/improvement. Partner with ... recommend, own, and implement corrective/preventative measures aimed at improving compliance and reducing repeat occurrences ensuring consistent quality standards… more
- Catalent (Philadelphia, PA)
- …management of materials at Catalent-Philadelphia. Assist in the enforcement of regulatory compliance through state, FDA, DEA, CDC, and USDA requirements. They will ... is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and...a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer,… more
- Insmed Incorporated (Bridgewater, NJ)
- …accurate records to include any impact to payroll deductions and benefits payments. Partner with legal department to ensure compliance with various federal, ... monitoring of the various plans and policies to ensure compliance with legal requirements and company objectives. This is...focus on personal wellness in a variety of ways. Partner with wellness vendors and supervise on-site wellness activities;… more
- Catalent (Manassas, VA)
- …Summary Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new ... a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer...PMO to ensure regions are aligned with GPO initiatives. Partner with Category leadership to develop and execute strategies… more
- Merck & Co. (Rahway, NJ)
- …includes operating model, culture, talent development, technology introduction, and compliance .- However, one co-lead remains focused on non-sterile pipeline ... management processes that govern operations, including tier, clinical siting and compliance councils. Key performance indicators range from quality and regulatory … more
- Merck & Co. (Rahway, NJ)
- …raw materials into finished drug product. These individuals are expected to partner with and support formulation development colleagues in further understanding and ... Successful candidates will collaborate closely with team members and partner groups including formulators, engineers, Quality, Safety, and Facilities management… more
- Eisai, Inc (Nutley, NJ)
- …work with various local and global functions to harmonize Roles & Skills and partner with the Global Data & Analytics Technology Lead (GDATL), ensuring that the ... policies and knowledge of related processes such as privacy, security, compliance etc.Demonstrated ability to lead and/or influence decision making, conflict… more
- Merck & Co. (Durham, NC)
- …project to construct the facility, process and technology introduction, compliance improvements, and manufacturing readiness to initiate production of commercial ... assignments.Ensure individually assigned aspects of the project proceed in compliance with cGMP, regulations, and our Company's Quality Management System.Supporting… more
- Merck & Co. (North Wales, PA)
- …areas of focus include:the assurance of deliverable quality and process compliance ,effective deliverable development utilizing global and TA standards that optimize ... graphics) using global and TA standards and according to quality, compliance and timeliness requirements.-Expertise in SAS and clinical trial programming including… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner with various Technical Operation functions in support of personalized cell ... minimally invasive instrumentation tasks which support calibration interval extension. Partner with stakeholders assist in defining user requirements for new… more
