- Formation Bio (New York, NY)
- …and internal and external GMP related audits. Collaborate with and provide Quality oversight to contract manufacturing, packaging/labeling, and testing partners. ... to patients faster and more efficiently.About the PositionThe Sr. Director, GMP Quality Assurance will lead the GMP QA strategy and execution for Formation… more
- BioAgilytix (Durham, NC)
- …skillsProficiency in MS Excel and WordProficiency in LIMS and Quality Management software packagesAdditional ResponsibilitiesOther duties as neededMinimum Acceptable ... build proficiency in MS Excel, MS Word, LIMS and Quality Management softwarePreferred CredentialsExperience with shipping and receiving procedures Familiarity… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance, or manufacturing compliance.Expertise in GMP compliance knowledge ... including knowledge of 21 CFR Part 11, EU Annex 11 among othersExperience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred.Thorough knowledge and understanding of GMP data integrity standardsKnowledge of cGMP… more
- Aequor (Thousand Oaks, CA)
- …This position is a business support role in Sample Coordination in Quality Control. It will involve interacting with multiple functional areas including Raw ... Materials, Manufacturing, Stability, Contract labs and internal labs. This role will be both remote and on campus, depending on business need, Monday through Friday,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …reconciliation and negotiation of Vendor contracts prior to study termination and contract closure. Manages all aspects of sourcing and negotiating Vendor contracts ... efficiencies and cost controls.- Communication and Relationship Management- Leads contract related communication with vendors. Respond to questions from internal… more
- Merck & Co. (Tallahassee, FL)
- …to support customer operational and financial needs such as reimbursement information and contract adherence in an effort to help the provider or system increase ... care pro viders such as physicians, nurses, pharmacists as well as quality directors, immunization managers, and office managers. W ithin their geography there… more
- Genmab (Plainsboro, NJ)
- …areas, further develop our QA organization, manage resources, and ensure compliance with quality standards.In this role, you will lead a global team of around 60 ... US. Main responsibilities include:Provide QA leadership to the global Quality Assurance team at Genmab.Strengthen and develop the QA...in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well… more
- Genmab (Plainsboro, NJ)
- …integral role in driving strategy development, planning, and execution of high- quality scientific publications across Genmab's Hematology portfolio. This role will ... with both internal and external disease-area experts to ensure high quality analysis, interpretation, communication, and publication planning of data.In development… more
- Genmab (Plainsboro, NJ)
- …Manager you will play a pivotal role in ensuring the timely delivery of high- quality clinical trial supplies for both early and late-stage trials. In addition, this ... in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well...the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. SummaryAccountable to lead, manage and ensure that all Contract Manufacturing, Testing and Warehousing organizations contracted by or on behalf ... global markets are also met.Cross-Functional Team Participation: Responsible for working with Quality Leaders in each operating site to influence and affect the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …expectations for products. The incumbent is responsible to adhere and maintain Quality Management System and GMP Compliance Programs to assure product quality ... activities, and supporting complaint and recall programs. This position interacts with Quality Assurance (QA) sub-functional and cross-functional teams, as well as … more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …for directing and managing regulatory strategies for multiple pipeline and contract manufactured products. The Director plays a leadership role in interactions ... Director of Regulatory Affairs will also interact with many consultants, Exela's contract clients and internally with several departments including R&D, Quality ,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …packaging, QA, compliance and audit.Demonstrated experience dealing with contract manufacturing organizationsMust have solid understanding of quality ... and immune disorders. SummaryAccountable to manage and ensure that all Contract Manufacturing, Testing and Warehousing organizations contracted by or on behalf… more
- Genmab (Plainsboro, NJ)
- …processing.Proactively monitors and strives to maintain high levels of quality , accuracy, and process consistency in field incentive compensation planning ... annual awards trip and promotion criteria based on performance.Manage quality controls and quality assurance in the...in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well… more
- Merck & Co. (Rahway, NJ)
- …CSS team with IS&O initiatives and daily operations, adopting high- quality change practices and embodying our Companys Enterprise Leadership Skills.Stakeholder ... and operational effectiveness.Audit Participation: Serve as the key contact for contract documentation to support global audits and data requests across categories… more
- Formation Bio (New York, NY)
- …integrated in house clinical trial execution strategy and outsourcing to a Contract Research Organization (CRO) when needed. Support the selection, contracting, and ... performance of Contract Research Organizations (CROs) and other external vendors when...Ensure that clinical trials are conducted to the highest quality standards, with a focus on patient safety, data… more
- Merck & Co. (Rahway, NJ)
- …and instrument-related issues.Collaborate and liaise with external partners and Contract Research Organizations (CROs) to manage the development, validation, and ... with CROs, demonstrating skills in clear communication, protocol transfer, quality agreements, secure data transfer, and regulatory compliance.Proficiency in… 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 ... to ensure all trial deliverables are met according to timelines, budget, quality standards and in compliance. Proactively track, monitor and report trial risks,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …outside contractors/vendors to complete tasksSupports and/or owns technical and quality investigations, CAPAs and correctionsDevelops and performs any required ... and Annual Product ReviewsWorks in a collaborative team setting with Quality , Manufacturing Operations, Facilities & Engineering Quality Control, Operations… more
- Genmab (Plainsboro, NJ)
- …according to timelines, budget, operational procedures, regulations, guidelines, and quality standardsManage a team of 25+ scientists within Clinical Pharmacology ... well as budget planning & managementSignificant publication record in high- quality journals, references, and external presentations demonstrating relevant experienceProven… more
