- Novo Nordisk Inc. (West Lebanon, IN)
- …records. Will be a QA presence on the manufacturing floor. Relationships Quality Assurance . Essential Functions Reviews all manufacturing and support records ... compliance with specifications and procedures Releases product based on Quality Assurance record review and approval by...Performs regular internal audits of NNUSBPI facilities as a lead auditor Works closely with Manufacturing and Quality… more
- Aequor (Thousand Oaks, CA)
- …equivalent combination of education and/or experience. Typically 2 plus years of related quality assurance or manufacturing experience in a GMP pharmaceutical or ... Global Incoming Quality Process Operations to support Global Process Owner lead . Interface with IQA Network, various sites and business partners to ensure… 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 ... customers around the world. Ours is a high energy team of dynamic, innovative individuals dedicated to advancing our...outstanding opportunity for an enterprising data and analytics technology leader who will thrive in a dynamic environment and… more
- Eisai, Inc (Nutley, NJ)
- …Management: Create a regulatory / non-regulatory change review and change management process. Team Leadership: Lead the global teams in the execution of ... you.The Director, Global IT Governance, Risk & Controls Management Lead is responsible for overseeing the entire portfolio of...& Architecture, s/he is the Global IT department's trusted leader and manager who assesses and provides objective risk… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …submission and compliance of all required DS documentation for quality control/ assurance , legal, finance, operational and educational requirements.Operates ... OEDC metrics (ie KPIs, KQIs, and other speed and quality metrics) through the use of dashboards.Coordinates communication of...of committee communications and responses. - The OEDC Program Lead leads an agile team in a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …expertise and solutions to CSV questions and issues.Responsibilities- Provide Validation Lead support for Daiichi Sankyo GxP and Non-GxP computer systems ... implementations in partnership with Global DX, and QA-CSV/eCompliance team members to ensure compliant, efficient and timely completion of global DX GxP and Non-GxP… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and partners to ensure that deliverables are met according to agreed timelines and quality standards. Lead a team of professionals specializing in ... testing strategies and processes to ensure all systems and solutions meet the required quality standards, collaborate with quality assurance teams to ensure… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …is seeking a QA Investigations Lead (1st or 2nd shifts) as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Investigations Lead has the ... candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell… more
- Merck & Co. (Rahway, NJ)
- …clear performance goals and metrics for the team to drive excellence.Device Quality OversightOversee the quality assurance of complex devices, such as ... will play a pivotal leadership role within the organization, overseeing the quality assurance and regulatory CMC for complex medical devices, including… more
- Christus Health (San Antonio, TX)
- …customer service, leadership, and displays a positive attitude * Responsible for Quality Assurance testing as required by regulatory agencies and/or Manufacture ... to the daily operations of their clinical area. This leader ensures the delivery of high- quality images...the ability to coordinate the teamwork of the healthcare team , assigning and directing staff, and overseeing the daily… more
- Merck & Co. (Upper Gwynedd, PA)
- …effectiveness. This will include ongoing partnership with the Research & Development Division Quality Assurance (QA) and acting as the link between Clinical ... quality data from clinical trials conducted worldwide. In collaboration with the Clinical Quality Operations Lead {CQOL and Head of Clinical Quality … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an Associate Director of Quality Project Management and Strategyas part of the Quality team based in Raritan, NJ. Role OverviewThe Associate Director of ... candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Biotech is seeking Quality Project Management Specialist as part of the Quality team based in Raritan, NJ. Role OverviewThis position is an exempt ... is preferable that the candidate have 2 years + of experience working in Quality Assurance . Previous cell therapy experience is a plusKnowledge of cGMP… more
- Tris Pharma (Monmouth Junction, NJ)
- …and manages the Quality Assurance (QA) Investigations and Product Quality Complaints Team to ensure manufacturing quality controls and procedures ... and technology make us unique, but it is our team members that set us apart; they are the...Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality … more
- Aequor (Thousand Oaks, CA)
- …(presents confidently and convincingly at all level of the organization). Expert skills in lead and managing people and team 's management of diverse cultures and ... as internal network functions within Operations including: Supply Chain, Quality , Process Development, Manufacturing, Global Strategic Sourcing and Finance. This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Alliance Committee. b. Quality leadership team c. Develop/ chair or co- lead quality council as necessary.Ensure the vision is in place to build the ... duties under the RDPV QA function to ensure that Quality assurance oversight are being addressed and...readily available for presenting at senior leadership meetings.Ensure and lead the establishment of the Quality Systems… more
- BioAgilytix (Durham, NC)
- …a strong working relationship and open communications with all departments, including Quality Control, Quality Assurance and Sample ManagementTrack project ... a strong working relationship and open communications with all departments, including Quality Control, Quality Assurance and Sample ManagementPrepare Sample… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …patient-specific, finished drug product batches by collaborating with all functions (including Quality Assurance , Quality Control, Operations, Vein to Vein, ... Planner, Batch Logistics as part of the Supply Chain team based in Raritan, NJ. Role OverviewThe CAR-T Batch...of relevant work experience in Operations, Supply Chain, or Quality Assurance experience within a cGMP environmentFacilitate… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... a QA Shop Floor Supervisor as part of the Quality Operations team based in Raritan, New...directly supervising employees is preferred.Ability to work with and lead others in a team environment.Demonstrated ability… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …packaging and labeling. This position will interface with Operations, Regulatory, Quality Assurance , Finance, R&D, Project Management and Quality ... information on the request for pricing (RFP) process.Direct and coach cross functional team staff in areas such as quality , compliance, safety, project planning,… more
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