- Merck & Co. (Millsboro, DE)
- …as needed. - Assists in the management and execution of critical quality systems such as change control, document management, Deviation management, ... Job DescriptionThe Senior Quality Specialist ensures product/process quality system adherence and batch record review, completes quality checks and SAP… more
- Merck & Co. (Durham, NC)
- …manufacturer? If so, then this is the opportunity for you! The Lead Maintenance and Instrumentation Technician is responsible for providing equipment troubleshooting ... an inclusive team culture including significant interaction with Operations, Quality , Automation, Technology, and other groups as required.-Under the supervision… more
- Merck & Co. (Rahway, NJ)
- …Experience supporting compliance investigations and change management. Experience working with Quality systems . Experience working in an environment with an ... degree of technical, project, and people management responsibility. - This SSO Facility Lead role within the SSO Pilot Plant leverages significant depth and breadth… more
- Repligen (Clifton Park, NY)
- …protocols preferred.Proficient in Microsoft Office (Excel, Word, Outlook) and ERP systems such as SAP.Leadership Competencies:Demonstrated ability to lead and ... OverviewThe Manufacturing Lead plays a key role in the success...day-to-day leadership and direction to production teams, ensuring safety, quality , and efficiency standards are consistently met or exceeded.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …potential suppliers, manage RFI/RFP and term sheet development, and negotiate contracts. Lead cross-functional teams and collaborate with Quality , Legal, CMC, ... immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Category Sourcing Lead as part of the Global Operations team based in Raritan, NJ. Role… 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a seasoned IT SAP Finance Director to lead the design, delivery and continuous improvement of SAP Finance solutions across our ... SAP Finance implementations, upgrades and integrations (including S/4HANA), ensuring quality , on-time and on-budget execution.Provide leadership and direction to a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a difference? The Position The Patient Safety, Compliance & Operational Excellence Lead is responsible for driving efficiency, quality , and innovation across ... GxP Compliance Training and Patient Safety Operations. This role ensures that Safety/ Quality /Training processes, systems , and resources are optimized to support… more
- Cipla (Central Islip, NY)
- …properly documented and approved according to regulatory requirements. Create and enforce quality systems and procedures to ensure consistent product quality ... Job Title QMS Lead - Investigations Organization Name InvaGen Pharmaceuticals, Inc....and corrective actions. Work closely with QA, AQA, operations, quality control, and other departments to gather information and… more
- Rocket Lab Corporation (Long Beach, CA)
- …Introduce automation where appropriate and ensure equipment data links directly to MRP and quality systems Lead a team of manufacturing engineers through ... Lab is a global leader in launch and space systems . The rockets and satellites we build and launch...the quality team to resolve manufacturing engineering quality responsibilities, and when required, lead problem… more
- Merck & Co. (Millsboro, DE)
- …(freeze-drying) capacity being built at the site.This role is the Technical Lead for Lyophilization with both deep scientific experience and practical commercial ... manufacturing judgment. You will lead technical strategy, science-based technology transfer and scale-up of freeze-drying and fill-finish processes for vaccine and… more
- Merck & Co. (Rahway, NJ)
- …Director Packaging Technical Operations the Director Packaging Distribution, Components and Systems Center of Excellence (COE) is responsible and accountable for ... molecule bulk and primary packaging components and packaging master data and systems .The Packaging Technical Operations organization aims to be an industry leader in… more
- Formation Bio (New York, NY)
- …them for regulatory inspections. Overseeing the development, implementation, and upkeep of quality systems and procedures, including SOPs, batch records, and ... and external teams to implement corrective and preventive actions. Lead the quality review process, ensuring the...requirements, including GMP, GCP, and ICH guidelines. Expertise in Quality Management Systems (QMS). Extensive knowledge of… more
- Merck & Co. (Rahway, NJ)
- …Management System (QMS) documents pertaining to USDA requirements for facility design, auditing, quality systems and ensure team and company adherence to these ... Associate Director, will report to the Animal Health Global Quality Compliance and Technical Lead .-- The responsibility...Quality Management, Quality Management System Auditing, Quality Management Systems (QMS), Quality … more
- BioAgilytix (Durham, NC)
- …That means hands-on work designing Azure Data Factory and API integrations, automating data- quality checks, and setting up clear governance so everyone knows who can ... keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data governance framework, with hands-on… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …strong knowledge of regulatory frameworks (eg, FDA), GCP guidelines, and quality management systems .Preferred but Not Mandatory: Medical practice experience ... 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
- Aequor (Thousand Oaks, CA)
- …System organization. Under general supervision, provide tactical support activities to Quality Management System Lead . Specific responsibilities include but are ... Does the thought of building an entirely new digital quality management system, excite you? Do you love to...that support the Digital QMS Maintain knowledge of current systems , tools, standard methodologies, and terminology and ensure adherence… 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
- Eisai, Inc (Nutley, NJ)
- …and drive execution as a part of that plan.Champion CQA's mission of ' Quality as enabler of business'; lead global initiatives for continuous improvement.Trend ... If this is your profile, we want to hear from you. The Clinical Quality Assurance Professional (QAP) position is responsible for design, delivery and execution of… 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
