- Legend Biotech USA, Inc. (Raritan, NJ)
- …the promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based ... in Raritan, NJ. Role OverviewThe Quality Systems Lead role is an exempt level position with responsibilities for supporting the quality systems … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole Summary:The USMA Health Systems (HS) Director, Strategic Medical Implementation Lead , plays a critical leadership role in advancing the ... major initiatives with robust 30/60/90-day milestone tracking.Performance Measurement & Analytics Lead Health Systems value creation by identifying areas of… more
- Tris Pharma (Monmouth Junction, NJ)
- …guidelines, standards and objectiveOversees and manages maintenance and tracking of Quality Systems including, but not limited to: Investigations/OOS/OOT/Lab ... and product quality complaintsEngages in activities to continuously assess/improve quality systems by identifying and proactively resolving quality … more
- Merck & Co. (Durham, NC)
- …pharmaceutical manufacturer? If so, then this is the opportunity for you! The Lead Tech, Engineering is a member of the Engineering team providing technical support ... an inclusive team culture including significant interaction with operations, quality , automation, technology, and other groups as required.Key Duties:Ability to… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for defining and ... around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation,… more
- Novo Nordisk Inc. (Durham, NC)
- …our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate ... Team Novo Nordisk and help us make what matters. The Position Serve as a Lead & Subject Matter Expert (SME) to provide technical expertise supporting site data and… more
- Merck & Co. (Rahway, NJ)
- …products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems . The director will lead a team of engineers and technical ... proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management systems .Qualifications:Bachelor's degree in Mechanical Engineering, Biomedical… more
- Apex Systems (Charlotte, NC)
- …is to stop any debit card payments if something flags it as being compromised. Lead a variety of systems quality assurance testing initiatives on software ... systems Act as key participant in planning for systems quality assurance Lead testing, development, and project teams to provide training, resolve… more
- Aequor (Thousand Oaks, CA)
- …Drug Product Formulation and Vial/Syringe Filling operations Experience with various quality systems including change control, deviations, corrective and ... Lead within the New Product Introduction, Manufacturing Execution Systems , and Digital team at ATO B20. The NPI...value to the network: Manufacturing, Process Development, Supply Chain, Quality , and Facilities & Engineering. A high degree of… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …& relevant processes. Ensures alignment of training processes to corporate & quality systems . Responsible for maintaining Standard Operational Procedures (SOPs) ... Extensive knowledge in training principles, knowledge management, and instructional systems design preferred Knowledge of pharmaceutical manufacturing quality … more
- Merck & Co. (Durham, NC)
- …make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant ... connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates, and finished products.The Sr. Specialist, Calibration… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization responsible for either the non-sterile or sterile ... size.Responsible for multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics; these metrics will… more
- Merck & Co. (Durham, NC)
- …sites.- This includes Energy Center, Vaccine Bulk and Manufacturing Facilities, Quality Labs, Material Management Storage Facility (MMSF) and projects. At times, ... problem solving sessions to support investigations and develop appropriate CAPAs which lead to program improvements.Review and approve out of tolerance (OOT) records… more
- Insmed Incorporated (San Diego, CA)
- …supporting clinical GMP drug substance and drug product production and quality control operations. This role combines technical leadership in equipment lifecycle ... management with oversight of calibration and maintenance systems to ensure operational readiness and regulatory compliance. Responsibilities include leading the… more
- Twist BioScience (South San Francisco, CA)
- …experienced and highly motivated Manufacturing Execution System (MES) Director to lead the strategic development, implementation, and optimization of our custom, ... across our biomanufacturing operations. This critical role will drive efficiency, quality , and robust data integrity within a highly automated environment. The… more
- Aequor (Thousand Oaks, CA)
- …change the world. In this pivotal role, you will report to the Planning Lead within the Global Supply Chain Organization and will be accountable to deliver strong ... of network initiatives to drive improvements in Supply Chain processes, systems , and procedures. Interfaces across functions including Supply Chain, Manufacturing,… more
- Eisai, Inc (Indianapolis, IN)
- …hear from you. The Area Business Leader (ABL) will engage with assigned health systems for Eisai's oncology portfolio and manage a team of sales professionals. The ... (S-suite, C-suite, KOLs, Pathway and PandT committee members). Each ABL will lead account responsibility for a defined number of potential strategic accounts and… 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, ... its' Performance Qualification and Process Simulation execution, the selected candidate will lead and contribute to the launch and regulatory certification of the… more
- Aequor (Houston, TX)
- …the most likely cause of the deviation investigation o Familiarity with cGMP quality systems , and demonstrates ability to read and comprehend GMP documents ... cause of the deviation investigation Knowledge Familiarity with cGMP quality systems , and demonstrates ability to read...processes for investigations Willing to pursue opportunities that can lead to substantial benefit, even if there are risks… more
