- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Investigator Compliance Specialist as part of the Technical Operations team based in Raritan, ... NJ. Role OverviewThe CAR-T Compliance Auditor (Sr. Investigator) will be a key member...in CAR-T process technologies with a strong focus on compliance auditing, risk assessment, and continuous improvement.The Compliance… more
- Merck & Co. (Durham, NC)
- …accordance with OSHA and other regulatory agencies- Identifies and addresses compliance , environmental, safety, and process deviations as required and escalates to ... 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. (North Wales, PA)
- …FDA regarding select US topics, primarily including: drug shortages, user fee compliance , import/exports, financial disclosure and freedom of information. This is an ... the tracking, coordinating and reporting of specified financial information to ensure compliance with the US Food and Drug Administration requirements for "Financial… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …across the global safety organization. The incumbent will ensure regulatory compliance , promote best practices, foster a culture of continuous improvement in ... tool(s).Perform monitoring and tracking of the signal workflow to ensure compliance with procedural documents.When required, assist the product safety teams in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …audits, and high impact projects, fostering s culture of excellence and compliance and working toward building a quality mindset with Medical Affairs.Support the ... Management:Lead the end-to-end quality execution across Medical Affairs programs, ensuring compliance with GCP, GPV, GPEP, Data Protection, and other local… 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 ... with external suppliers and partners to ensure the quality and compliance of components used in Autoinjectors, driving performance, accountability, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.Key Responsibilities ... manufacturing process.Supervise manufacturing and manufacturing support activities for cGMP compliance through spot checks/internal audits.Collaborate with site personnel to… more
- Merck & Co. (Rahway, NJ)
- …with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Utilize extensive experience in design controls, ... transfer programs in both development and lifecycle management, ensuring compliance with relevant regulatory standards.Ensure robust technical plans, risk… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oversee all regulatory activities related to the review, approval, and compliance of advertising and promotional materials for the company's pharmaceutical products. ... assessing the impact of labeling language on promotional strategies to ensure compliance and alignment with commercial objectives. This individual will also play a… more
- Merck & Co. (Durham, NC)
- …a focus on safety, current Good Manufacturing Practices (cGMP) compliance and efficiency.Define requirements and specifications for equipment.Manage the ... should be able to examine an issue from diverse perspectives (safety, compliance , automation, equipment, process, and people) in order to best understand and… 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
- Merck & Co. (Rahway, NJ)
- …which the Senior Specialist is responsiblePV Statement preparation in compliance with relevant regulations, policies, and proceduresSame/similar designation of ... accordinglyProvide oversight of team projects/activities, including tracking progress and compliance with projected timelinesFacilitate group meetingsManage team questions and… more
- Merck & Co. (Rahway, NJ)
- …with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities: Strategic Leadership and Project Management: Provide ... transfer programs in both development and lifecycle management, ensuring compliance with relevant regulatory standards.Ensure robust technical plans, risk… more
- Merck & Co. (Rahway, NJ)
- …result in outcomes that demonstrate the Company's dedication to regulatory compliance .Ensures that a cross-functional team (eg Quality & Continuous Improvement (QCI) ... provide real-time, proactive advice and guidance.Escalates potentially significant inspection findings/ compliance risks/impact to Company Senior Management.Develops the inspection management… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …during the execution of regulatory inspections and audits as needed.Support compliance activities for site Quality Operations in accordance with Legend standards, ... quality indicating data and identifying trends.Contribute to maintain investigation compliance metrics.Support investigation process improvement initiatives.Job duties performed may… more
- Merck & Co. (Irving, TX)
- …management direction, coordinates production associates to meet production schedules in compliance with the Quality System, EHS and company policies while ensuring ... the manufacturing manager to ensure production schedules are met.Verifies compliance of machinery and equipment prior to production runs.Immediately reports… more
- Merck & Co. (Durham, NC)
- …area/process overview information to visitors/auditors upon request-- Quality & Safety Compliance - Foster strong safety culture on the team through actions, ... reporting safety issues and completing corrective/preventative actions-Drive culture of compliance through actions, consistent quality-driven decision making, and coaching… more
- Merck & Co. (Rahway, NJ)
- …investigations with a strong focus on quality and regulatory compliance .Excel in impurity isolation, unknown peak identification, characterization of degradation ... chainIntroduce and lead strategic initiatives related to technical advancement, compliance , and business improvements.Demonstrate the ability to influence meaningful… 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 ... and follow-up of regulatory applications and ensure quality and compliance across all documentation.Interact independently with regulatory agencies (FDA, EMA,… more
- Tris Pharma (Monmouth Junction, NJ)
- …supplier relationship management, procurement systems functionality/workflows and assurance of compliance with GxP and other company and regulatory agency ... procurement policies and procedures throughout the organization. Ensures compliance with all current GxPs, Food and Drug Administration (FDA), Drug Enforcement… more
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