• Exela Pharma Sciences, LLC (Lenoir, NC)
    Position Summary:Oversee and lead the validation program for production equipment and processes used to support manufacturing of aseptic and terminally sterilized ... products. Lead the validation team in the establishment and maintenance of validated...capability. Support manufacturing to satisfy the quality and process validation requirements for existing products. Participate in the development… more
    HireLifeScience (03/16/24)
    - Save Job - Related Jobs - Block Source
  • Insmed Incorporated (Bridgewater, NJ)
    …in New York™, and Best Workplaces for Millennials™ lists.OverviewManage the Validation Lifecycle for GxP System/Application Implementation Projects Develop CSV Plans ... following: Manage day-to-day operations of the GxP function within ITCoordinate all validation activities with outsourced validation vendorAuthor CSV Documents (… more
    HireLifeScience (03/12/24)
    - Save Job - Related Jobs - Block Source
  • Novo Nordisk Inc. (Durham, NC)
    …Relationships Manager . Essential Functions Ensure accuracy & compliance of validation & equipment records Responsible for validation of QC equipment ... help us make what matters. The Position Plan, manage & perform laboratory validation activities. Routine review of laboratory validation procedures & completed … more
    HireLifeScience (03/08/24)
    - Save Job - Related Jobs - Block Source
  • Aequor (Thousand Oaks, CA)
    …Understands contracting negotiations. is searching for a Capital Projects Sourcing Manager , who will be responsible for helping execute the sourcing processes ... Strategic Sourcing (GSS) department in a fast-paced environment. The Capital Projects Sourcing Manager will report to the Category Senior Manager for Capital… more
    HireLifeScience (03/28/24)
    - Save Job - Related Jobs - Block Source
  • Novo Nordisk Inc. (West Lebanon, IN)
    …eligible for selected candidate. Relationships Reports to: Sr. Operational Excellence Manager plus additional interfacing with Manager of Automation Engineering ... to identify roles and responsibilities Work closely with Engineering, Automation, Validation , IT, Manufacturing, Quality Assurance and Quality Control, on project… more
    HireLifeScience (03/27/24)
    - Save Job - Related Jobs - Block Source
  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …other research areas centered around rare diseases and immune disorders.Job Summary The Manager , Data Programming & Reporting is a member of the Biostatistics and ... of work includes oversight and expertise in the design, development, and validation of programs, standard and adhoc reports, standard and exception data listings,… more
    HireLifeScience (01/18/24)
    - Save Job - Related Jobs - Block Source
  • Novo Nordisk Inc. (West Lebanon, IN)
    …assistance eligible for selected candidate. Relationships Reports to: Sr. Manager Operational Excellence. Number of subordinates with direct/indirect referral: 6 ... (cGMP)/ regulated pharmaceutical or biotechnology industry Experience in development, validation , start-up and continuous improvement of manufacturing processes is a… more
    HireLifeScience (03/27/24)
    - Save Job - Related Jobs - Block Source
  • Exela Pharma Sciences, LLC (Lenoir, NC)
    Position Summary The Manager of Automation Engineering leads Automation Engineers and contractors responsible for instrumentation and controls of manufacturing ... providing input, as necessary.Support the generation and execution of Validation life cycle documentation such as Systems Commissioning, Installation Qualification… more
    HireLifeScience (02/10/24)
    - Save Job - Related Jobs - Block Source
  • Catalent (San Diego, CA)
    Senior Manager , Quality AssurancePosition Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies ... Site Leadership Team, you will partner with the General Manager to create and sustain a site culture of...and approve GMP documentation, including SOPs, Manufacturing Batch Records, validation protocols and reports, and executed Batch Records for… more
    HireLifeScience (02/14/24)
    - Save Job - Related Jobs - Block Source
  • Novo Nordisk Inc. (West Lebanon, IN)
    …Manufacturing Sciences & Analytical Technology, Quality Assurance, Quality Control, and Validation , on project teams to facilitate design, transfer, and start-up of ... and performance metrics for all projects under guidance of tenured project manager Lead cross functional teams focused on improving manufacturing or business… more
    HireLifeScience (03/20/24)
    - Save Job - Related Jobs - Block Source
  • Novo Nordisk Inc. (Plainsboro, NJ)
    …Part D, & Managed Care contracts. This role is responsible for ensuring the validation of formulary eligibility for invoicing of all Commercial and Part D rebates as ... and contract compliance. Relationships This individual contributor role reports to the Sr. Manager of Business Assurance and works closely with various teams in PCOR… more
    HireLifeScience (03/01/24)
    - Save Job - Related Jobs - Block Source
  • Catalent (St. Petersburg, FL)
    QA Product ManagerPosition Summary The QA Product Manager provides customer service, with the highest integrity, focused on quality and compliance with partnership ... within the Catalent St. Petersburg site. The QA Product Manager is responsible for the overall Quality Assurance review...projects and Product Development Projects; c) all product process validation and cleaning validation documents; d) all… more
    HireLifeScience (02/23/24)
    - Save Job - Related Jobs - Block Source
  • Catalent (St. Petersburg, FL)
    …to the safety of every patient, consumer and Catalent employee. Compliance Manager is responsible for providing Leadership and Quality Assurance Management support ... Document Control, Equipment/Facilities, Change Control, etc. The focus of each QA Manager may be dependent upon the needs of the business and structure… more
    HireLifeScience (02/22/24)
    - Save Job - Related Jobs - Block Source
  • Eisai, Inc (Nutley, NJ)
    …your profile, we want to hear from you. Job Summary The Senior Manager , Translational Science Biostatistics will be expected to work independently with minimal ... analysis of human biomarker datasets to inform biomarker identification and validation , clinical development and business strategies. As the study statistician, this… more
    HireLifeScience (02/03/24)
    - Save Job - Related Jobs - Block Source
  • Merck & Co. (Durham, NC)
    Job DescriptionThe Senior Project Manager is responsible for providing project management support for our Company manufacturing sites in Durham, North Carolina. This ... and ensure input and alignment from all members (facilities, maintenance, validation , quality, regulatory, etc )Work with and provide guidance to auxiliary… more
    HireLifeScience (03/23/24)
    - Save Job - Related Jobs - Block Source
  • Merck & Co. (Durham, NC)
    Job DescriptionThe Project Manager is responsible for providing project management support for our company's manufacturing sites in Durham, North Carolina. This ... and ensure input and alignment from all members (facilities, maintenance, validation , quality, regulatory, etc )Work with and provide guidance to auxiliary… more
    HireLifeScience (03/23/24)
    - Save Job - Related Jobs - Block Source
  • Lundbeck (Bothell, WA)
    …growing biologics pipeline in collaboration with our Copenhagen-based Process Science & Validation Team.The Lu-SBP team leads and supports the development of new ... product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes. Join us on our journey of… more
    HireLifeScience (01/20/24)
    - Save Job - Related Jobs - Block Source
  • Novo Nordisk Inc. (Plainsboro, NJ)
    …resources as required. Direct reports will include Application Architects, Project Manager and Business Analyst. Essential functions Analyzes and fulfills business ... and/or functional area Manages the implementation and operation of Adobe Experience Manager (AEM) platform (on-prem and in the cloud) solution which fully meet… more
    HireLifeScience (03/06/24)
    - Save Job - Related Jobs - Block Source
  • Novo Nordisk Inc. (Durham, NC)
    …of raw materials & provides quality oversight, review & approval of validation activities associated with minor changes to existing systems. Performs archiving ... & QA presence & process confirmation on shop floor. Relationships Manager , Quality Assurance. Essential Functions Ensures site compliance with Regulations, ISO… more
    HireLifeScience (02/07/24)
    - Save Job - Related Jobs - Block Source
  • Exela Pharma Sciences, LLC (Lenoir, NC)
    …manufacturing equipment in accordance with site Change Control and Validation requirementsPerform investigation of manufacturing eventsPerform process & engineering ... processing techniques preferredKnowledge of pharmaceutical product development, manufacturing processes, validation , cGMP's and FDA regulations for the Pharmaceutical IndustryProficiency… more
    HireLifeScience (02/27/24)
    - Save Job - Related Jobs - Block Source