- BioAgilytix (Boston, MA)
- …here at BioAgilytix.Essential ResponsibilitiesPerform Quality Control (QC) technical, scientific, and compliance review of data and documentation generated by ... OOS and OOT associated with Bioanalytical Operations data as applicableIssue QC review observations and work closely with the scientific staff to ensure data… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking Director, Global Process Validation as part of the Technical Operations team based in Raritan, NJ. ... the global MSAT organization. This individual will be responsible for global process validation activities in support of the commercial Carvykti program both within… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Chain, Compliance , Quality Assurance, pharma-specific litigation issues, promotional brand review , etc.) preferred- 1 or More Years Relevant experience in ... around rare diseases and immune disorders.Summary The Associate Director, Privacy & Compliance Investigations, is a member of the Compliance Department who… more
- Novo Nordisk Inc. (Stamford, CT)
- …safety, rights and wellbeing; data reliability; scientific integrity; regulatory and process compliance ) for monitoring and site management activities. Takes ... exceeding the Novo Nordisk points threshold assigned based on review of Motor Vehicle Records.; May be required to...and level within the job family during the recruitment process . The base range of pay for each title… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the Global QA mission across boundaries and with different stakeholders. Continuously review compliance metrics trends from regulators/ industry experts and ... responsible for QA GMP activities pertinent to the overall compliance state of DS drug substance, drug product and...Chain and Pharmaceutical Technology functions in the vendor selection process to assure that all newly selected vendors are… more
- Merck & Co. (Millsboro, DE)
- …at our company's Millsboro Animal Health facilities. This role is highly compliance -driven in accordance with State and Federal regulations as applicable to the ... training and oversight of the animal care staff, serving as a designated reviewer and voting member of the Institutional Animal Care and Use Committee (IACUC),… more
- Merck & Co. (Rahway, NJ)
- …and operational experience to lead and support facility operations, process development activities, compliance investigations/change management, authoring of ... through participation in equipment design and testing as well as preparation, review , and completion of GMP documentation. Support compliance with Industrial… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …medical support. Support MLs with ISS development, such as providing independent reviewer support when needed Analysis and translation of insights and Competitive ... provide on-going support, as determined by Field Director Ensure personal compliance with all internal/external SOPs/rules and regulations regarding NNI products,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Quality Compliance Lead as part of the Quality team based in Raritan, NJ. Role ... Overview The Quality Compliance - Lead Auditor CAR-T is responsible for regulatory ...the implementation, execution, and improvement of the internal audit process . Support the planning and execution of internal audits… more
- Eisai, Inc (Nutley, NJ)
- … policies based on regulatory changes.Establish a regulatory change management process for modifying technological functions and compliance controls.Monitor and ... want to hear from you. Job Summary: As the Americas IT Security and Compliance Director, you play a pivotal role in ensuring the organization's adherence to… more
- Merck & Co. (Rahway, NJ)
- …and provide specific input to forecast and budget for site financial process . Ensure compliance requirements, eg, Safety, Good Manufacturing Practice (GMP), ... operations to develop shared support goals and achieve service level agreements. Review project design commissioning documents for revisions and acceptance Propose… more
- Merck & Co. (Rahway, NJ)
- …Pilot Plant is a Good Manufacturing Practices (GMP) facility within the Process Research and Development (PR&D) organization, which enables gain of critical internal ... of new manufacturing technology/processes, training opportunities for improved manufacturing process development, and seamless technology transfer to commercial sites.The… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …responses submitted to health authorities globally with respect to data standards, compliance , etc. May represents the function at health authority meetings. Reviews ... input to TLF shells for submission documents (eg, ISE and ISS). Develops the process for ensuring that analysis data sets and outputs are compliant with regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …responses submitted to health authorities globally with respect to data standards, compliance , etc. May represents the function at health authority meetings. Reviews ... input to TLF shells for submission documents (eg, ISE and ISS). Develops the process for ensuring that analysis data sets and outputs are compliant with regulatory… more
- Buckeye Community Health Plan (Obetz, OH)
- …close to Columbus is preferred. Position Purpose: Lead and direct process improvement activities that provide more efficient and streamlined workflow. Bachelor's ... Organize and control activities, methods, and procedures to achieve business objectives Review and implement new technological tools and processes and fosters team… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …collaborative relationship with EU QPPV as necessary. External Engagement Continuously review compliance metrics trends from regulators/ industry experts and ... Reviews of respective product profile to ensure appropriate management review of all quality and compliance related...modules in support of a proactive quality risk management process .Interact with the audit and compliance function… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for all GCO procedural packages and associated documents (including process maps) through cross-functional review cycles.Establish standard end-to-end ... responsible for the creation, management, and documentation of GCO's CRO SOP review and maintaining the master Daiichi Sankyo (DS) SOP list for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Compliance leads to product high quality labeling documentation.Establishes Process Best Practices: Serve as a role model for less experienced members ... lead the development of Standard Operating Procedures (SOPs) and process improvements. Conduct team meetings with direct reports or...and Company Core documents as well as for the review of country labeling deviations.Ensure Compliance with… more
- Novo Nordisk Inc. (Boulder, CO)
- …us? The Position The Product QA Specialist will be responsible for the review and approval of GMP clinical pharmaceutical batch production records while maintaining ... a subject matter expert and trainer in batch record review as well as assist in coordination and communication...packaging, and analytical records for data integrity and GMP compliance and consistency with company policies and procedures necessary… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and forecasting for commercial and IMP relevant activities and QA batch review and release process as necessary.Complaint and Recall Programs Establishment: ... of Standards and Procedures (SOPs) and Training Activities: Responsible for development and review of procedural documents that set compliance in QA GMP… more
