- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and regulatory requirements for GMP area. Responsible for the creation and review Quality Assurance Agreements with contract organization and to manages a ... Quality Assurance Agreement system which provides a...quality standards to meet patient needs. Responsible to lead the activities related with stability studies program performance… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …a collaborative team setting with quality counterparts that include Manufacturing Operations , Operations Technical Support, Maintenance, Supply Chain and ... as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Investigations Lead has the responsibilities for providing quality oversight over… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … Leaders in meetings with quality counterparts that include Manufacturing Operations , Operations Technical Support, Maintenance, Supply Chain and ... Supervise a team of QA Investigations Leads.Provide guidance to the Quality Leaders about handling the various nonconformances. Lead the daily touch point… more
- Aequor (Thousand Oaks, CA)
- …or Power point or other tools to translate visuals. Quality background Quality management system in operations and R&D. Analytical skill set, experience with ... of the GxP Management Review Governance Team within the Quality Systems and Services organization. The QA ...reporting of applicable metrics for GxP L0 Management Reviews. Lead the digitalization of GxP L0 Quality … more
- Merck & Co. (North Wales, PA)
- …the decision. Operate with Integrity and ensure adherence with organization policies, quality assurance and data protection processes.Conduct innovation proof of ... Line Leader, this role will be responsible for the technical delivery aspects of the end-to-end data capabilities and...data products. The role influences and ensures timely and high- quality value delivery across all aspects of the data… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Lead Operations Gowning Trainer as part of the Technical Operations team ... Program and be responsible for the gowning training and qualification of Manufacturing, Quality ( QA ), Quality Control (QC) associates for the production… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Associate Director, Quality Technical , is responsible for leading a team that supports deviation management, change control, site ... or related disciplines with six (6) years of experience.Preferred Experience and Skills: Quality Assurance and/or cGMP experienceMinimum of 2 years managerial… more
- Merck & Co. (Rahway, NJ)
- …efficient solutions.Define and enforce coding standards, development methodologies, and quality assurance processes.Drive innovation in SAP development ... the EIT SAP Platform Team, the EIT SAP Technology Lead will assume the crucial role of leading all...a DEV/OPS SAP technology team, responsible for development/ governance/ operations of the enterprise-wide technical SAP ERP… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe GRACS Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business ... and collaborates with internal and external functions such as our company's QA , GCD Standards, and Learning & Development. This collaboration is essential in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …individual will need to build strong partnerships with Training, SMEs, and Quality Assurance to ensure seamless execution of daily training and ... with others to drive continuous improvements and efficiencies within cell therapy Technical Operations .RequirementsA minimum of a Bachelor's Degree in Science,… more
- Aequor (Thousand Oaks, CA)
- …The position must work closely with Environmental Health Safety Services (EHSS) and Quality Assurance ( QA ) for compliance. The position will support ... The staff works in partnership with the maintenance, Project Management, Engineering Technical Lead , and manufacturing to develop and oversee the operation… more
- Merck & Co. (Rahway, NJ)
- …members, fostering a collaborative and innovative team environment.Regulatory Compliance and Quality Assurance :Ensure that all activities are conducted with the ... syringes, and other drug delivery systems. The director will lead a team of engineers and technical ...working collaboratively with receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality .Provide Voice… more
- Merck & Co. (North Wales, PA)
- …Strong listening skills.Demonstrated sound understanding of related fields (eg, manufacturing, analytical, quality assurance ) and the ability to be creative and ... sections for commercial or new biologics products. The Principal Scientist will lead the development and the implementation of internal regulatory strategies and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …team setting with quality counterparts that include Manufacturing Operations , Quality Control, and Operations Technical Support. Manage people to ... candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance , Medical Affairs, Translational Research, Research, ... solution needs and produce preliminary solution design and architectural diagrams. Lead technical feasibility discussions, prototype development, and design… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …cGMP requirements. You document proposals to reach a solution with relevant stakeholders (eg QA , C&Q, Operations , ). You will develop root cause analyses in the ... failures (increasing availability), but also on increasing EHS & QUALITY compliance or reducing costs (without reducing availability). He/she...the basis of an asset management system.You take the lead in new projects and also provide technical… more
- Rhythm Pharmaceuticals, Inc (Boston, MA)
- …Quality Assurance provides strategic leadership and direction for clinical quality assurance operations and other prioritized needs, ensuring Rhythm's ... with internal and external stakeholders. Lead , develop, and mentor the clinical quality assurance team, responsible for the execution and sustainability of… more
- Page Mechanical Group, Inc. (Boston, MA)
- …industry experience and technical background across GxP encompassing Production, Quality Assurance , Clinical Development and Quality Control. Should ... Assurance is responsible for establishing and leading Aveo's Quality Management System (QMS) operations and ensuring...DUTIES: Lead and manage a high performing quality staff designed to meet the technical … more
- Pulmonx Corporation (Redwood City, CA)
- …Affairs & Quality AssuranceThe Vice President, Regulatory Affairs and Quality Assurance implements regulatory strategies worldwide to 1) ensure that ... Affairs teams with respect to clinical studies involving Pulmonx products.Oversee the Quality Assurance team during facility inspections and audits of the… more
- Merck & Co. (Lower Gwynedd, PA)
- …our vaccines pipeline. The individual will be responsible to lead vaccine bioanalytical assay development, qualification/validation, technology transfer, and/or ... junior staff, building relationships with stakeholders, and providing expert technical representation on multidisciplinary teams will be expected.Responsibilities: Provide… more
