- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Quality Assurance Director will provide compliance leadership and direction to our Company and contract manufacturing operation (CMO) ... (API), biologics, vaccine drug substances and finished products. As Director , you will support Quality audits and...Inspection, Quality Management, Quality Management Systems (QMS), Quality Metrics, Regulatory Compliance… more
- Merck & Co. (Rahway, NJ)
- …design verification testing, and process validation, with a strong understanding of quality management systems and regulatory compliance .Exceptional project ... products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems . The director will lead a team of engineers and technical… more
- Merck & Co. (Rahway, NJ)
- …a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines ,- strategies and ... the efficiency, accuracy, and effectiveness of clinical supply planning processes and systems . - Stay updated on industry trends, regulations, and best practices… 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 ... is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director...Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard… more
- Merck & Co. (Upper Gwynedd, PA)
- …Scientist, CMC, R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr Principal Scientist in Pre-approval Pharmaceutical CMC is ... responses to health authority questions per established business processes and systems .-Identify, communicate and escalate potential regulatory issues to GRACS CMC… more
- Insmed Incorporated (San Diego, CA)
- …process development support testing function within analytical development. Will develop systems and processes to facilitate rapid, high throughput testing. As the ... on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to take care of the… more
- Merck & Co. (San Francisco, CA)
- Job Description Position Description: Associate Director , DSCS Digital Implementation Project ManagerWithin the Development Sciences and Clinical Supply (DSCS) ... interdependent across our functional areas, Discovery, our Manufacturing Division Quality , and BARDS, to name a few, and with...of the DSCS Digital Program Mgmt Lead, the Associate Director , DSCS Digital Project Manager, will be responsible for… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole Summary:The Executive Director , Value & Implementation (V&I) Outcomes Research position resides in the V&I organization, which includes Global ... payers, policymakers, health technology assessment (HTA)/ reimbursement agencies, and health systems globally. The ability to successfully participate in and lead… more
- Tris Pharma (Monmouth Junction, NJ)
- …strategies and operations, contract negotiations, supplier relationship management, procurement systems functionality/workflows and assurance of compliance with ... systems to maintain optimal stock levels and minimize obsolescence; Ensures compliance with safety, quality , and regulatory standards in warehouse… more
- Merck & Co. (Rahway, NJ)
- …Standard Operating Procedures (SOP) and current GXP documents.Experience with quality systems .Excellent organizational skills.Desire and willingness to learn, ... Data-Driven Decision Making, Drug Product Development, Estimation and Planning, GMP Compliance , Management Process, Manufacturing Quality Control, Medical Supply… more
- BioAgilytix (San Diego, CA)
- …Chemistry departments. This role oversees daily laboratory operations, scientific quality , and regulatory compliance across both functions, supervising ... up to 40 employees.The Director will focus approximately 95% of their oversight on regulated bioanalytical studies in biological matrices using LC-MS/MS, supporting… more
- Twist BioScience (South San Francisco, CA)
- …MES professionals, primarily software developers, who work in concert with Manufacturing Operations, Quality Assurance, and R&D. The Director will serve as the ... Sr. Director , Manufacturing Execution System (MES) (Hybrid in South...and data visualization capabilities to support operational decision-making and quality reviews. Compliance & Validation: Ensure our custom… more
- Eisai, Inc (Exton, PA)
- …close-out of documentation, manufacture of DS/ADI materials, and suite change-over ensuring compliance to relevant regulations. The Associate Director is also ... profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible...with other Development groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory, and CMC… more
- Merck & Co. (Durham, NC)
- …Drug Delivery Systems and Devices within our Manufacturing Division (Associate Director ).-This role serves as a Virtual Plant Manager - responsible for leading a ... Compliance , Supply, Continuous Improvement, and Cost Management.--The Associate Director , External Manufacturing Operations will also assist in commercialization… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …cutting-edge AI/GenAI technologies and developing AI/GenAI products to deliver high quality insights with speed and efficiency Promotes a culture of creativity ... the Novo Nordisk US Operations, including ED&AA, IT, Ethics and Compliance , Commercial, Patient Services, CMR (Clinical, Medical, Regulatory), Finance, and Novo… more
- Repligen (Clifton Park, NY)
- …will play a key role in delivering the site expansion programs, implementing quality management systems and maintaining ISO certification. The individual will ... functions and have personal development plans.Ensure that the operation is in compliance with all aspects of Repligen's IS09001 Quality Management Responsible… more
- USAA (Phoenix, AZ)
- …of what truly makes us special and impactful. The Opportunity As a dedicated Director , Underwriting Research , you will be responsible for Managing a team of staff ... and programs while balancing operational efficiency, competitiveness, and regulatory compliance . Implementation may include overseeing business configuration efforts, including… more
- Solon Community School District (Cedar Rapids, IA)
- The Solon Community School District is seeking a dedicated and organized Director of Transportation to lead the district's student transportation services. This ... communication, and the ability to learn and navigate transportation software systems with ease. Basic Responsibilities: Transportation Management & Safety Fleet &… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This role ... in overseeing the development, validation, implementation, and integration of GxP-regulated systems across the organization. This position ensures that all global … more
- Merck & Co. (Rahway, NJ)
- …regulatory submissions.-Under the general scientific and administrative direction of the Director in Biologics Cell Culture Sciences group and working in conjunction ... a cross-functional team.-Ensures project results meet requirements regarding technical quality , reliability, schedule, and cost.Monitors performance and recommends schedule… more
