- Merck & Co. (Durham, NC)
- …6:30 PM; 6:00PM-6:30AM) rotation ( 2-2-3).- - The Vaccine Manufacturing Facility Lead Technician is an excellent opportunity for highly motivated individuals with ... expertise working in aseptic production and manufacturing operations. The Lead Technician is a manager developmental role and will serve on the Operations leadership… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical development processes through KQIs, demonstrating process control and ensuring compliance levels are met. Lead the process for reviewing and assessing ... audits, and high impact projects, fostering s culture of excellence and compliance and working toward building a quality mindset with Medical Affairs.Support the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …teams on key milestones relating to the tracking of a particular signal(s) to ensure compliance with global Sops. Lead the maintenance of signal tool and support ... the material content of any documents sent to regulatory authorities. Provides compliance metrics to management, as needed. Lead continuous improvement around… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionApplications are sought for a Process Engineering Lead position in o ur Reseach & Development Division Biologics Process Research & Development ... as an engineering resource for biologics operations, build strong equipment knowledge, lead projects, and provide guidance and training to operationalize the GMP… more
- Merck & Co. (Durham, NC)
- …opportunity to experience licensure and ramp up to full production.Durham's Lead Technician, Operations will be a leader with strong interpersonal, communication, ... supporting the manufacturing process. This individual will possess the ability to lead a team, train others and contribute to and implement process improvements.This… more
- Merck & Co. (Millsboro, DE)
- … compliance with corporate and regulatory requirements (cGMP/USDA) and lead IPT support for audits, inspections, validations and corrective actions.Author, review ... Job DescriptionJoin our Millsboro Senior Leadership team and lead a high-impact Integrated Process Team that directly influences site performance, product quality… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. Role ... OverviewThe QA Investigation Lead is an exempt level position reporting to the...the execution of regulatory inspections and audits as needed.Support compliance activities for site Quality Operations in accordance with… more
- Merck & Co. (Durham, NC)
- …technical solutions and operational improvements to achieve targets for safety, compliance , supply, and productivity for the product franchise. This role requires ... to strategic workstreams, knowledge sharing, and process improvement projects. Lead projects through all phases including project planning, project management… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for designated team members.Support Investigations team by providing quality and compliance input for continuous improvement; and remediations. Lead quality ... responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.Key Responsibilities… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Manufacturing Lead Operator as part of the Technical Operations team based in Raritan, ... is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.Shift Schedule:… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … lead investigations to ensure process integrity and GMP compliance . Additionally, the role includes overseeing and enhancing manufacturing standards, ... in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Investigator Compliance Specialist as part of the Technical Operations team based in Raritan,… more
- Merck & Co. (Upper Gwynedd, PA)
- …existing Data & Analytics (D&A) products and link usage to business outcomes. Lead data transformations, data quality, data governance, advanced analytics, and data ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Merck & Co. (Durham, NC)
- …technical solutions and operational improvements to achieve targets for safety, compliance , supply, and productivity for the product franchise.This role requires a ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, NJ. Role OverviewThe ... Quality Systems Lead role is an exempt level position with responsibilities...Preventive Actions (CAPA) process and is responsible for ensuring compliance within quality systems processes.Key Responsibilities Provide oversight to… more
- Merck & Co. (Durham, NC)
- …and schedules project/work meeting the criteria established by site objectives.Support & lead Utility equipment related projects, scope including but not limited to ... groups to ensure facility operations and systems comply with required standards. Lead / participate in discussions with contractors, vendors, or other third-party… more
- Merck & Co. (Rahway, NJ)
- …expertise in the design, development, and manufacturing of Autoinjectors, ensuring compliance with industry standards and regulatory requirements (eg, ISO 13485, FDA ... seek out, anticipate, and solve significant scientific and technical challenges. Lead complex investigations into technical challenges related to design,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionIn partnership with the Clinical Quality Operations Lead (CQOL and Head of CQO, the CQOM is accountable for the execution of operational quality ... for maintaining appropriate levels of knowledge and skill in order to effectively lead and support GCP inspections, worldwide.- Under the guidance of the CQO … more
- Merck & Co. (Rahway, NJ)
- …and the efficient management of data across the organization, including compliance with regulatory standards, and the optimization of laboratory operations and ... technologies, and data analytics to enhance data utilization and compliance , streamline processes, and improve overall operational efficiency in laboratory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of the Senior Director/Director, GMA Oncology (Global Medical Affairs team lead for compound), is responsible for assisting with defining compound/program medical ... and market access discussions for select indications.- Support as medical lead for select company-sponsored GMA evidence generating studies/projects. Manages all… more
- Merck & Co. (San Diego, CA)
- …with global regulatory authorities to ensure successful registration and compliance . Global Immunology submission experience in IBD strongly preferred. Primary ... Responsibilities Develop and lead global regulatory strategies to support multiple indications, optimizing labels and achieving timely regulatory approvals.Serve as… more
