- 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 ... Legend Biotech is seeking Associate Technical Lead as part of the Technical Operations team...process monitoring program. Establish metrics for process and team performance . Ensures seamless flow of knowledge and information across… 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 ... career. Are you ready to realize your potential? The Position This position will lead a team of professionals and be responsible for the design, implementation, 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
- Novo Nordisk Inc. (Durham, NC)
- …confirmation on shop floor Ability to support all processes & functions in Department Quality Risk Management Make decisions on quality & compliance issues ... life-changing careers, and the opportunity to help improve the quality of life for millions of people around the...technologies. What we offer you: Leading pay and annual performance bonus for all positions All employees enjoy generous… more
- Formation Bio (New York, NY)
- …data, identify trends, and implement proactive measures to mitigate risks and improve quality performance . Excellent problem-solving skills, with the ability to ... and documentation to ensure the consistent production of safe, effective, and high- quality pharmaceutical products. Lead internal and external audits to assess… 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
- 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
- CosmoProf (Columbus, OH)
- …8 districts in partnership with RLPM and HRBP. Accountable for profit and performance goals set forth by the company. Maintains an effective level of business ... Assesses District Mangers to identify talent opportunities which impact District performance . Consistently engages District Managers in discussions around their own… 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
- 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
- Formation Bio (New York, NY)
- …data, identify trends, and implement proactive measures to mitigate risks and improve quality performance . Excellent problem-solving skills, with the ability to ... faster and more efficiently.About the PositionThe Sr. Director, GMP Quality Assurance will lead the GMP QA... Agreements with external partners. Monitor CDMO and vendor performance and ensure timely resolution of quality … 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
- Merck & Co. (Rahway, NJ)
- …is a plusTranslate use cases into implementation roadmaps to deliver high quality data productsEstablish common performance expectations and processes for data ... you will be part of the HHDDA Commercial Data Solutions team and lead Digital Product Management capabilities role, driving shaping and delivery of impactful… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …This role will foster innovative approaches and processes to enhance business performance and drive sustainable growth across the organization. This role involves ... and contribute positively to business growth and success. Relationship Reports to Launch Excellence Lead and dotted line to TA Integrated Lead / Brand Lead… more
- Aequor (New Brunswick, NJ)
- …processes and tools to evaluate performance and enable proactive data-driven risk detection and decision-making. Lead the development of GSC pillar metrics ... and implementation of GSC initiatives to improve and ensure long-term organizational performance and process efficiency.Plan, manage, and lead projects and/or… 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 ... potential? Join Team Novo Nordisk and help us make what matters. The Position Lead and manage Emerging Technologies (ET) / Solid Dosage Forms (SDF) production site… more
