- Legend Biotech USA, Inc. (Raritan, NJ)
- …transfer and manufacturing operations.Support writing of SOPs for Manufacturing and Quality Risk Assessments for existing and new/changed processesAbility to ... immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Associate Technical Lead as part of the Technical Operations team based in Raritan, NJ.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... processes and implementing changes to enhance efficiency, productivity, and quality Resource Management: Managing resources such as personnel, equipment, and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …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 ... Are you ready to realize your potential? The Position This position will lead a team of Validation Engineers and Validation Technicians, and is responsible for… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and participate in manufacturing documentation such as Protocols, Batch Records and Risk Assessments.Review and participate in quality event records, such as ... Aseptic Manufacturing LeadPosition Summary:The Aseptic Manufacturing Lead plays a critical role in overseeing aseptic manufacturing activities. A strong background… more
- Merck & Co. (Durham, NC)
- …approving change controls. Approve cleaning validation documentation as needed. May act as a Quality Risk Assessment Lead . - - Education Minimum Requirement: ... or drug product. GMP experience with qualification of equipment. Experience with Quality Risk Management. Project Management experience in a highly regulated… more
- Merck & Co. (Rahway, NJ)
- …input/output requirements, including but not limited to chemical, physical, or performance specifications. Lead and manage development of Global Design file ... Job DescriptionReporting to the Director of Medical Device and Combination Product Quality Assurance, the Associate Director Quality Engineering & Quality … more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …for results and company performance .Must set the expectation for the company in quality mindfulness and lead by example. Must be able to sit and/or stand ... strong internal audit program and robust management reviews.Drive strong quality performance and continuous improvement: Customer ComplaintsCAPA… more
- Merck & Co. (Durham, NC)
- …skill sets in planning / scheduling, and time management.Experience with Quality Risk Management.Experience with Deviation Management.Experience with Kneat, ... Quality Assurance Organization, will independently manage Shop Floor Quality Assurance team on second shift. Lead a...and procedures that impact the team's ability to meet performance objectives and metrics.- Consults on an as-needed basis… more
- Merck & Co. (Rahway, NJ)
- …dive" quality assessments such in data integrity and leading cross-functional contractor performance reviews as the quality lead for the oversight ... manufacturing and 10 years overall within biopharmaceuticals.Planning and facilitating high risk and highly complex Quality -related process reviews and/or… more
- Tris Pharma (Monmouth Junction, NJ)
- …implement improvements, including CAPAs and CPIs, across departments as appropriateApplies quality risk management principles in the design (and resolution) ... needs and activities in to accurately, effectively, timely and compliantly achieve quality goals and key performance metrics across multiple quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …application and other key drivers of enhanced quality .Aligns with the RBQM Risk Management Lead on critical-to- quality factors and study-level critical ... Sankyo functions globally and with external parties as required.Champions ' Quality by Design' and Quality Risk..., quality tolerance limit (QTL) libraries, and critical-to- quality factors. Lead RBQM Center of Excellence for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …managed appropriately.Provide oversight of the CRO to ensure compliance with Daiichi Sankyo's quality measures. Leads the creation of the Risk Identification and ... operational planning, start-up, conduct, reporting, and close out) including timeline, quality , and budget management. Drives and leads the successful execution of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …& Leadership:Has primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan including ... CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, Operations… more
- Merck & Co. (Durham, NC)
- …supply performance metrics ( Schedule Adherence , Release on Time, Customer service performance , Product Lead Time, etc.) . - - Continuous Improvement - ... work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work...facility . T his role will contribute to the performance and results of a E2E drug substance/product department… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to ... reconciliation reports, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements. Oversees the execution… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …project plans across functional teamsDefines the interdependent deliverables and ensures that quality , risk , cost, time are managed within the overall approved ... discipline and its application to drug development required to deliver time, cost, quality , and risk management to teams.Demonstrated results in creating and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …concept to implementation.Support writing of MBRs and SOPs for Manufacturing and Quality Risk Assessments for existing and new/changed processesAbility to work ... and consumables for compatibility with the Manufacturing process.Draft Process Risk Assessments for implementation of process changes.RequirementsBS/BA required in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …objectives. Implement and use efficient project management tools, eg, Communication Plan and Risk Based Quality Monitoring documents, such as Risk Assessment ... Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop… more
- Aequor (Thousand Oaks, CA)
- …and performance management. Responsibilities, include: Assist the Staff Relations Lead in supporting US Operations Partner with the Occupational Heath, staff and ... Recommend solutions to a variety of staff relations issues including managing poor performance , managing conflict, and assessing risk (escalating issues to the… more
- Genmab (Plainsboro, NJ)
- …CPQS in the Translational and Quantitative Sciences Leadership Team and lead strategic development of pre-clinical and clinical pharmacology strategies for Genmab's ... a culture of continuous learning and improvement.This is an exciting opportunity to lead a passionate, high profile, high-impact Pharmacology team, and work in a… more
