- Merck & Co. (Rahway, NJ)
- …Content Management Systems (CMS), Cross-Cultural Awareness, Data Management , Data Quality Assessments, Documentation Review, Employee Training Programs, ... BE ONSITE 3 DAYS PER WEEK)The Submissions Content Source Management Business Operations Lead is expected to...and attention to detail Preferred: Experience with other content management systems such as DocumentumAdvanced knowledge and… more
- Merck & Co. (Rahway, NJ)
- …Devices Design, Negotiation, Process Manufacturing, Product Design, Production Process Development, Project Management , Quality Management Systems (QMS) ... Machine Learning (ML), Manufacturing Processes, Mechanical Testing, Medical Device Quality Systems , Medical Device Regulations, Medical Devices, Medical… more
- Merck & Co. (Durham, NC)
- …focus teams; advise, problem-solve, and drive continuous improvementImplement and oversee fit-for-purpose Quality Management Systems and standard ways of ... Communication, Entrepreneurship, Execution Excellence, Influence, Leadership, Networking and Partnerships, Program Management , Quality Management Systems … more
- Merck & Co. (Ames, IA)
- … Auditing and Supplier ManagementThe Director will report to the Animal Health Global Quality Lead for Compliance and Technical Support and will direct the below ... aspects of the Supplier Quality Management (SQM) and Animal Health global...through ongoing training and continuing education programs.Coordinate with Site Quality leads on audit refusals and postponements. Lead … more
- Merck & Co. (Rahway, NJ)
- …(RaDS) value team in our Company's R&D IT brings together product management , engineering, and data science expertise. We enable data, technology and services ... RaDS Product organization. The position will report to the Lead of the Disease Biology and PharmTox Product Line....vendor relationships to influence roadmaps and integrate with internal systems and the data lake.- Partner with product tech… more
- Cipla (Fall River, MA)
- …associates to ensure they are qualified prior to beginning their daily functions. Acts as quality lead for all shop floor questions/concerns. Acts as back up for ... Job Title : Quality Assurance (QMS) Production Lead FLSA...documents. Provides daily/weekly updates to the shop floor and management regarding quality highlights/concerns. Creates lessons learned… more
- Repligen (Clifton Park, NY)
- …safety within the manufacturing area.Ensure compliance with all aspects of Repligen's Quality Management System and Quality Policy.Conduct performance ... manufacturing team. This position is responsible for the safe, efficient, and high- quality production of molded plastic components. The Lead will oversee… more
- Merck & Co. (Rahway, NJ)
- …quality and our company's standards and communicate project status to management .Act as Development Quality representative for in-house or outsourced ... Quality Control, Microbiology, Molecular Microbiology, Physiology, Process Improvements, Quality Assurance (QA), Quality Assurance Systems {+… more
- Repligen (Clifton Park, NY)
- …discussions.Uphold all company policies and ensure full compliance with Repligen's Quality Management System, EHS programs, and workplace conduct ... protocols preferred.Proficient in Microsoft Office (Excel, Word, Outlook) and ERP systems such as SAP.Leadership Competencies:Demonstrated ability to lead and… more
- Advanced Energy (Eden Prairie, MN)
- …+ Strong knowledge of ISO 9001 or similar quality management systems . + Proven ability to lead cross-functional teams and drive impactful quality ... & Design Quality ** + Lead end-to-end quality planning and risk management for new product development, ensuring robust design processes and compliance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …platforms Strong product development experience Strong knowledge of Content Management Systems related platforms (specifically, Adobe Experience Manager ... content operations team to manage content with high efficiency, quality and speed, and promotes adoption of design standards,...Enablement role will report directly into the Director, Content Management & Production Lead as part of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …OOS monitoring and trending program)Contribute to developing and/or improvements to quality systems in support of global implementation of changes ... initiatives.Experience in developing, writing and approving technical documents.Experience with Quality systems (Change control, investigations, LIMs, etc.).Extensive… more
- Twist BioScience (South San Francisco, CA)
- … and safety of our genomic products and services by implementing and maintaining a quality management system (QMS) that complies with ISO 13485 and ISO 14971. ... and participate in Internal Audits in addition to Supplier Audits.Ensure the Quality Systems group is appropriately staffed to ensure timely completion… more
- Merck & Co. (Rahway, NJ)
- …To act as master data stewards and support enterprise wide component specification management as well as maintaining documentation systems for the packaging ... Director Packaging Technical Operations the Director Packaging Distribution, Components and Systems Center of Excellence (COE) is responsible and accountable for… more
- Merck & Co. (Rahway, NJ)
- …of contact for manufacturing leadership, engineering, commercial teams, supply chain, quality , IT, and external partners/vendors. Lead stakeholder engagement ... security requirements appropriate for industrial environments. Requirements definition & systems design Lead scoping, requirements definition, and prioritization… more
- Formation Bio (New York, NY)
- …of global regulatory requirements, including GMP, GCP, and ICH guidelines. Expertise in Quality Management Systems (QMS). Extensive knowledge of quality ... them for regulatory inspections. Overseeing the development, implementation, and upkeep of quality systems and procedures, including SOPs, batch records, and … more
- Insmed Incorporated (NJ)
- …are seeking an experienced leader to oversee cybersecurity operations, enterprise risk management , and Computer Systems Validation (CSV) program. This role will ... EU GMP Annex 11, and GAMP 5 guidelines a plus .Experience collaborating with Quality , IT, and business stakeholders to ensure systems are validated and remain… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …abilities, strong knowledge of regulatory frameworks (eg, FDA), GCP guidelines, and quality management systems .Preferred but Not Mandatory: Medical practice ... OverviewThe Respiratory Clinical Development Medical Lead will oversee the clinical and medical aspects of new respiratory medicines, including new drug or 505(b)(2)… more
- Insmed Incorporated (NJ)
- …through Phase 3, ensuring compliance with GMPs and internal standards.Serve as the Quality lead for GMP activities supporting clinical trial materials, including ... supporting biologics, drug products, or combination products.Deep knowledge of phase-appropriate quality systems , regulatory requirements (21 CFR Parts 210/211,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and procedures for the signaling activities to ... all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead ...improvement around development of new signal workflow/process, development of quality systems and tools, updates to templates… more
