- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oversight of QA across GxP (GCP/GVL/GCLP/GLP) systems .Lead the development of the global Data Integrity strategy and promote a quality culture throughout the ... standards are met.Proactively assess and address operational gaps related to quality systems and compliance, fostering a culture of sustainable… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and/or new process versions in a regulated environment across a global manufacturing network.Familiarity with digital manufacturing systems (eg, MES, SCADA) ... initiatives.Work collaboratively with internal and external partners to drive global process platform improvements and cost reduction initiativesServe… more
- Merck & Co. (Rahway, NJ)
- …PurposeThe Director of GMP Compliance will report to the head of the Global Quality Compliance Support organization.- The responsibility of this position crosses ... documents meet major health authority GMP requirements-Provide consulting and research services to global QMS topic owners and site quality experts to assess the… more
- Merck & Co. (Rahway, NJ)
- …Supplier Management Systems , etc.Support MDCP sites with new/revised QMS Quality Standards and/or Global Procedures.Perform related duties, as assigned. ... be able to build relationships within a team environment.Experience using computer systems for Quality Management Systems .Must have working knowledge… more
- Aequor (South San Francisco, CA)
- …required by Roche's clinical trials seamlessly, on-time, and while optimizing cost/ quality . Within Production Enablement, the Global Clinical Materials Manager ... systems Drive and lead the issue management for global clinical supply concerning the procurement of drug products...Business Process Managers to exchange ideas, drive process improvement, and resolve issues on both global… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …on and manage multi-disciplined projects, with minimal supervision Understanding/application of quality systems Support of Health Authority inspections Possesses ... Control and Projects. Drives the coordination and execution of process and equipment improvement initiatives, reviews completed quality... documentation Ability to train others on the manufacturing process and QMS systems Revise and create… more
- Genmab (NJ)
- …to internal teams and vendors.Support cross-study harmonization of data quality practices. Process Excellence and Standards DevelopmentDrive the development ... and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …take on multi-disciplined projects, with minimal supervision Functional understanding/application of quality systems with the ability to manage Change Controls ... for Quality Control. Assists in coordination and execution of process and equipment improvement programs, creates technical reports, reviews completed quality… more
- Eisai, Inc (Nutley, NJ)
- …out routine, complex and for-cause audits Knowledge of data integrity controls and systems quality for clinical area Strong analytical skills and report writing ... process audits Facilitate Sponsor health authority inspections of global clinical facilities and study sites Continuously drive innovation through active… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible for ensuring ... for purpose and compliant with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality , CSPV, Clinical… more
- Aequor (Thousand Oaks, CA)
- …data. Additional responsibilities include providing and communicating results, maintaining global process trackers, develop project plan, support Business ... this position will perform routine procedures (ie, NC/CAPA/CC) and process improvements projects to support Corporate Quality ...by management. 4. Work within the Information Services and Quality Systems teams to foster good communication… more
- Novo Nordisk Inc. (Durham, NC)
- …Seeking an experienced to Sr level Process Engineer to support the bulk process tableting line. This role will improve/develop systems & equipment for the ... life-changing careers, and the opportunity to help improve the quality of life for millions of people around the...improvements. Develop plans to improve the performance of a process or set of systems , using green… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Nordisk's life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...commercial manufacturing facility. This role will work within our Process Engineering team focused on brownfield projects including: equipment… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Nordisk's life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well ... together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything… more
- Repligen (CA)
- OverviewRepligen Corporation is a global leader in bioprocessing technology and innovation, committed to redefining the limits of bioprocessing through advanced ... biopharmaceutical industry by delivering superior products that enhance efficiency, productivity, and quality of biologic drugs. As part of our dedicated team, you… more
- Merck & Co. (Durham, NC)
- …detailed understanding of design, construction, control and maintenance of building systems and process equipment. Provides technical support and training ... to mechanics and other maintenance personnel.Interface with safety, production, and quality groups to ensure facility operations and systems comply with required… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … systems across the organization. This position ensures that all global systems , electronic records, validation processes, and regulated applications meet ... driving the methodology, approach, and best practices for GxP systems while ensuring alignment with the Global ...and advocate for scalable, compliant architecture and design.Collaborate with global quality , IT, and business leaders to… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …GMP processes, Quality Management System (QMS), & standard improvement systems preferred Demonstrated expertise in leading process performance enhancements ... & relevant processes. Ensures alignment of training processes to corporate & quality systems . Responsible for maintaining Standard Operational Procedures (SOPs)… more
- Merck & Co. (Durham, NC)
- …technology systems , and develops strategies to optimize and ensure quality and stability of automation systems through future expansion, replacement, ... areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation. Our company… more
- Merck & Co. (Durham, NC)
- …technology systems , and develops strategies to optimize and ensure quality and stability of automation systems through future expansion, replacement, ... Manufacturing Practices (GMP), Lean Manufacturing, Manufacturing Processes, Problem Management, Process Automations, Quality Management, Real-Time Programming, Software… more
