• Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …accountable to global Development governance. In this key role, the candidate will have to lead a complex, global team in charge of a global clinical program ... of representative of asset through the lifecycle from research to post-marketing functions. Lead all GPT meetings, ensure team and cross functional alignment,… more
    HireLifeScience (03/20/24)
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  • Catalent (Harman, WV)
    …biologic, pharmaceutical or medical device industry performing direct hands-on work in a Quality Assurance/ Quality Control function with a strong familiarity ... independently under minimum supervisionAbility to work in fast paced environment supporting the quality assurance/ quality control departments of a CMO for… more
    HireLifeScience (03/27/24)
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  • Catalent (Harman, WV)
    …First culture at the site. The Head of Quality -Maryland is responsible for Quality , Validation and Quality Control and is the most responsible person ... approval of specifications, sampling instructions, test methods and other Quality Control procedures.Review and approve Site Annual...application to the site.Being part of the Site Leadership Team representing the QRA function for the site and… more
    HireLifeScience (03/22/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, 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
    HireLifeScience (01/10/24)
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  • Insmed Incorporated (Bridgewater, NJ)
    …Design Control Process for medical device products and combination products. Lead the quality assessment for product lifecycle changes, efficiency projects, ... years relevant experience requiredExtensive knowledge of cGMPs and pharmaceutical manufacturing, Quality Control and Quality Assurance.Commercial drug… more
    HireLifeScience (03/12/24)
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  • Insmed Incorporated (Bridgewater, NJ)
    …Computer Systems used to support the end-end GxP Supply chain including the Quality Management System, manufacturing, quality control , warehouse, and ... Document Management System, and additional GxP systems for Gene Therapy manufacturing, quality control , warehouse, and clinical operations. The position will… more
    HireLifeScience (03/12/24)
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  • Aequor (Thousand Oaks, CA)
    … systems. Knowledge of biopharmaceutical bulk and drug product development, manufacturing, and/or Quality Control Testing. As a Product Quality (PQ) ... will directly add to the success of the Product Quality team by collaborating with diverse functional...collaborating with diverse functional areas including Supply Chain, Manufacturing, Quality Control , Quality Assurance, Regulatory,… more
    HireLifeScience (03/02/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …well as other research areas centered around rare diseases and immune disorders.Summary Lead the implementation of the quality strategy closely aligned with the ... inspection readiness components for the designated programs. Ensure proactive representation of Quality professionals at strategic project team and at GCP… more
    HireLifeScience (02/24/24)
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  • Catalent (San Diego, CA)
    …responses. Communication and escalation of quality issues to Site Leadership Team and QA senior management. Lead programs for: QA department budget, Site ... Supplies facility. As a member of the Site Leadership Team , you will partner with the General Manager to...safety of every patient, consumer, and Catalent employee. The Role: Lead the development of site Quality Objectives,… more
    HireLifeScience (02/14/24)
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  • Novo Nordisk Inc. (West Lebanon, IN)
    …NNUSBPI facilities as a lead auditor Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, internal ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...self-starters with a strong work ethic to join our team . At Novo Nordisk, you will find opportunities, resources… more
    HireLifeScience (03/20/24)
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  • Novo Nordisk Inc. (West Lebanon, IN)
    …roles and responsibilities Work closely with Engineering, Automation, Validation, IT, Manufacturing, Quality Assurance and Quality Control , on project teams ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...day-to-day basis, and act as the central resource for team communication Lead project scope and deliverables… more
    HireLifeScience (03/27/24)
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  • Merck & Co. (Rahway, NJ)
    …Senior Director, Enabling Facilities, and will be a member of the EF leadership team at the Rahway NJ facility. EF is responsible for development of new ... group and the overall department strategy.- The Automation Leader will direct a team of automation engineers that administer automation systems residing in both -… more
    HireLifeScience (03/26/24)
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  • Novo Nordisk Inc. (West Lebanon, IN)
    …closely with Engineering, Manufacturing, Facilities, Manufacturing Sciences & Analytical Technology, Quality Assurance, Quality Control , and Validation, on ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...day-to-day basis, and act as the central resource for team communication Lead project scope and deliverables… more
    HireLifeScience (03/20/24)
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  • Merck & Co. (Durham, NC)
    …Maintenance (PMs) plans. Actively supports, participates and embraces an inclusive team culture including significant interaction with Operations, Quality , ... work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work...the operation. Must be able to function in a team -based empowered culture but perform successfully as an individual.… more
    HireLifeScience (02/28/24)
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  • Merck & Co. (Durham, NC)
    …Sr. Specialist must actively support, participate and embrace an empowered team culture including significant interaction with manufacturing, quality , IT, ... or review and approval of system commissioning and qualification documents, change control , automation incidents, Quality Notifications (QNs), and other key… more
    HireLifeScience (03/22/24)
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  • Merck & Co. (Durham, NC)
    …Maintenance (PMs) plans. Actively supports, participates and embraces an inclusive team culture including significant interaction with Operations, Quality , ... supporting our Manufacturing Division, Divisional site mission by assuring quality of products and services are of the highest...of the operation.Must be able to function in a team -based empowered culture but perform successfully as an individual.… more
    HireLifeScience (02/28/24)
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  • Merck & Co. (Rahway, NJ)
    …device combination products. Must be able to build relationships within a team environment. Experience using computer systems for Quality Management Systems. ... Job DescriptionAs a member of the Medical Device Combination Products Quality QMS group, the Associate Director, will participate in and/or lead various… more
    HireLifeScience (03/16/24)
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  • Merck & Co. (Rahway, NJ)
    …The Specialist - Manufacturing Automation position will report to the Director, Engineering, Automation Lead position and will be a member of the EF Team at ... automation systems across the Rahway Site including ABB Distributed Control Systems, environmental control systems and equipment...calibrated and qualified as required.- Also, this role will lead any future changes to the system such as… more
    HireLifeScience (03/20/24)
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  • Merck & Co. (Rahway, NJ)
    …Senior Specialist - Manufacturing Automation position will report to the Director, Engineering, Automation Lead position and will be a member of the EF Team at ... Specialist level will serve as technical SME and capital team member supporting the Modality Agnostic Chemistry Scaleup (MACS)...(SSO): - The SSO uses an Emerson DeltaV Distributed Control System.- The SSO is a Good Manufacturing Practice… more
    HireLifeScience (03/13/24)
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  • Catalent (San Diego, CA)
    …revision of new department-wide and site-wide procedures and company SOPs. Collaboration with Quality Assurance and Quality Control on analytical method ... of Scientist, Analytical Development will be expected to either lead projects independently or build a team ...committed to a Patient First culture through excellence in quality and compliance, and to the safety of every… more
    HireLifeScience (03/23/24)
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