- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Sr. Director , representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and ... and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director of...high impact projects, fostering s culture of excellence and compliance and working toward building a quality mindset with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …management processes across the global safety organization. The incumbent will ensure regulatory compliance , promote best practices, foster a culture of ... activities and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and… more
- Merck & Co. (Rahway, NJ)
- … development in addition to device development expertise.Strong familiarity with regulatory landscape associated with drug delivery combination product and ... verification testing strategies for innovative combination products?Join our company's Device Product & Process Development (DPPD) Team, which focuses on the design,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionSr. Principal Scientist - Device Technical and Engineering Lead (Sr. Director Equivalent)Our company's Device Product & Process Development (DPPD) ... years of leadership experience with deep working knowledge of device, biologic/drug product , and process development including regulatory submission and approval… more
- Merck & Co. (Rahway, NJ)
- …in alignment with the company's business goals, and quality and regulatory compliance .Essential Duties and Responsibilities:Program Leadership and Technical ... all activities are conducted with the highest regard for safety, quality, and regulatory compliance , aligning with the company's divisional and local site… more
- Merck & Co. (Rahway, NJ)
- …Program Management, Quality Management Systems (QMS), Quality Strategy, Regulatory Compliance , Risk Management, Stakeholder ManagementPreferred Skills: ... Job DescriptionWe're looking for a Director of Quality Assurance to lead quality across...of the Value Chain Management Team, guiding strategy, ensuring compliance , and enabling manufacturing excellence from development through commercialization.… more
- Merck & Co. (Rahway, NJ)
- …experienceRequired Skills: Audit Readiness, Drug Product Manufacturing, FDA Compliance , FDA GMP, FDA Inspections, FDA Regulatory Requirements, Inspection ... compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines.Ability to travel globally approximately 20-30% of the… more
- Merck & Co. (Rahway, NJ)
- …and drug product container closure systems including mold qualification and regulatory compliance .- To act as master data stewards and support enterprise ... Job DescriptionReporting into the Executive Director Packaging Technical Operations the Director ...and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across… more
- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and directing ... globally, coordinating departmental and cross-functional support.Responsibilities Designs and implements regulatory strategies to obtain, maintain product investigative… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting into the Director , Logistics and Distribution Technology the Associate Director , Logistics and Distribution Technology will be ... for distribution and logistics of human health Drug Substance, Drug Product and Finished Goods globally.-The Packaging Technical Operations organization aims to… more
- Merck & Co. (Rahway, NJ)
- …Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and Systems COE, the Director ... for distribution and logistics of human health Drug Substance, Drug Product and Finished Goods globally.- The Packaging Technical Operations organization aims… more
- Formation Bio (New York, NY)
- … vendors, for both development and manufacturing, ensuring high-quality deliverables and compliance with GMP and regulatory standards. Documentation: Author and ... review technical documents in collaboration with Quality colleagues to assure compliance with current GxP regulations. Regulatory submissions: Author, and… more
- Merck & Co. (Rahway, NJ)
- …activities-ensuring integration of HF principles to enhance patient safety and product usability. The Senior Director will champion enterprise-wide HF ... Job DescriptionThe Senior Director of Human Factors (HF) will provide visionary...represent the company externally to influence industry standards and regulatory practices.-Primary Scientific & Leadership Requirements - HF Influence… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Associate Director , Engineering as part of the Technical Operations team based in ... Raritan, NJ. Role OverviewThe Associate Director of Engineering is a strategic and operational leader responsible for the management, development, and performance of… more
- Merck & Co. (Rahway, NJ)
- …Plant Maintenance, Preventative Maintenance Programs, Process Control Systems, Project Management, Regulatory Compliance , Regulatory Requirements {+ 3 ... Job DescriptionAssociate Director HVAC : The HVAC Associate Director...Site.Develop, implement, and maintain HVAC operational strategies that ensure compliance with GxP (as applicable) and other regulatory… more
- Merck & Co. (Rahway, NJ)
- …to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Clinical Director May Be ... and manufacturing to manage clinical development projectsAssist the Senior Director , Associate Vice-President/Vice-President and Product Development Team Lead… more
- Merck & Co. (Rahway, NJ)
- …and pipeline products to produce safe, effective, innovative medicine.The Clinical Director is responsible for protocol development and medical/ scientific oversight ... addition to responsibilities associated with clinical research, the Clinical Director at this level will be expected to lead...at this level will be expected to lead a Product Development Team (PDT) through late-phase clinical development and… more
- SMBC (Jersey City, NJ)
- …+ Lead and contribute to large-scale, cross-functional projects to enhance regulatory compliance infrastructure. + Develop and deliver training materials ... portfolio of benefits to its employees. **Overview** As a Regulatory Policy Director at SMBC you will...in industry forums to discuss capital, liquidity, and other regulatory topics. **Technical Advisory & Product Analysis**… more
- SMBC (New York, NY)
- …**Role Description** **Overview** We are seeking an experienced and strategic **Executive Director ** to lead the **Payables and Receivables** product portfolio ... to deliver scalable, client-centric solutions that meet evolving market and regulatory demands. + Oversee product lifecycle management, including ideation,… more
- SMBC (New York, NY)
- …to facilitate the consistent cross functional delivery of New Business proposals in compliance with regulatory and group guidance. + Engage business leads and ... Manager with responsibility to facilitate the end-to-end delivery of new product and new business activity initiatives. Working closely with stakeholders across… more
