- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... with corporate objectives and complies with local market regulations and standards .- Establish a consistent and standardized LinkedIn page experience across all… more
- Merck & Co. (Rahway, NJ)
- …global human health.Responsibilities: The Senior Statistical Programmer, Submission Data Standards Quality Management (SDS QM), provides oversight and quality ... vaccine clinical development projects. Accountability predominantly includes submission data standards planning activities, coaching and consulting with project teams,… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …resource allocation, ensure regulatory compliance, and uphold rigorous scientific standards . Understanding best industry practices, will identify opportunities for ... opportunities to develop additional revenue streams.Regulatory Oversight: Uphold the highest standards of quality and compliance with all regulatory bodies to… more
- Repligen (Waltham, MA)
- …root cause investigations, and ensuring Repligen's supplier network meets regulatory and quality standards . This role is based in Waltham, MA, and will report to the ... Notifications to ensure compliance with internal and regulatory quality standards .Coordinate cross-functional teams to assess and mitigate risks associated with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... meet strict regulatory requirements, industry best practices, and internal quality standards . The Lead is responsible for defining and driving the methodology,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …NNI Patient Safety Contracts and NNI Patient Safety/Global Patient Safety standards and processes as applicable Develops comprehensive, relevant resources (eg ... (21 CFR FDA Post-Marketing), global/local SOPs, and other governing standards (ie. Good Pharmacovigilance Practice (GVP), requirements Maintains proficient… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Patient Safety Accountable for ensuring alignment with NNI PS /Global Patient Safety standards and processes as applicable Function as a Quality Point of Contact ... regulations (21 CFR FDA Post-Marketing), global/local SOPs, and other governing standards Maintains proficient understanding of the operational business laws and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... rare diseases and immune disorders. Job Summary: This position oversees ICSR Standards activities, projects, and procedures. This level interacts within global CSPV… more
- Merck & Co. (OH)
- …activities relative to the customer strategy, keeping with our Company's values and standards as governed by our policies and ensuring that our Company is viewed ... engage customers.Engage in all job responsibilities and activities with the highest standards of ethics and integrity, with particular emphasis on compliance with… more
- Merck & Co. (Rahway, NJ)
- …global filingsExperience on a large capital project team, knowledgeable of the Sterile Standards and equipment design standards , and understanding of project / ... engineering work process and deliverables (eg, equipment fabrication, FAT, SAT, qualification / validation)Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that… more
- Genmab (NJ)
- …development of new therapies by ensuring integrity, consistency and adherence to standards of data and produces well-structured, high quality data summaries in ... the establishment and maintenance of Genmab SDTM and ADaM database standards .Performs database standards consistency checks on databases delivered by… more
- Repligen (Rancho Dominguez, CA)
- …Identify and implement process improvements, ensuring compliance with industry standards and regulations. Develop and maintain engineering documentation including ... Flat Sheet Membranes) Strong knowledge of ISO 9001 and GMP manufacturing standards . Proficient in SolidWorks/CAD, MS Office, and electronic file management systems.… more
- Lundbeck (Indianapolis, IN)
- …Managing Execution Sets and maintains competent product knowledge and selling skills standards within the team. Directs and monitors the execution of approved ... and quality of work from self and others. Assures adherence to all standards , policies, procedures and guidelines as set forth by the organization. REQUIRED… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... maintains oversight of PV relevant contracts. Contribute to overseeing and setting standards for PV contract management. Review contributes to revision of DSI… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and equipment used at the site.Develops and evaluates quality processes and system standards to ensure compliance with applicable Legend standards , industry ... standards , and global regulations.Interacts with colleagues in Quality and Technical Services proactively to assess, and guide in the deployment of systems at the CAR-T Raritan SiteReview and approve change controls, SOPs, non-conformances, and CAPAs… more
- Tris Pharma (Monmouth Junction, NJ)
- …regulations, as well as all applicable company compliance guidelines, standards and objectives Leads and/or oversees functions (ie, purchasing/procurement, ... minimize obsolescence; Ensures compliance with safety, quality, and regulatory standards in warehouse operationsManages, coaches and mentors direct reportsRequirementsREQUIRED… more
- BioAgilytix (Durham, NC)
- …ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards :Develop a foundational data governance framework, with hands-on ... responsibility for data quality, access control, and compliance protocols.Define standards , build quality assurance processes, and monitor data integrity to meet… more
- Repligen (Hopkinton, IA)
- …equipment to ensure conformance to the organization and customer quality standards .ResponsibilitiesThe QC Inspector I will be responsible for:Conduct inspection of ... bioprocessing equipment, military or aerospace industry inspection practices and standards .Requires demonstrated use of basic Microsoft Office tools (Outlook, Excel,… more
- Merck & Co. (North Wales, PA)
- …and report programming development and validation utilizing global and TA standards and following departmental SOPs and good programming practices.Maintain and ... mind that optimize analysis and reporting and leverage departmental standards and industry best-practices.Ability to anticipate stakeholder requirements.** Preferred… more
- Merck & Co. (Durham, NC)
- …Lead influences site leadership ensuring compliance with regulatory requirements, corporate standards , policies, and procedures related to EHS as well as industry ... assure continuous compliance with local, state and federal legislation, Company standards and industry best practices, investigate and mitigate risks across… more
