- Merck & Co. (Rahway, NJ)
- …(RCQM), and in collaboration with the Clinical Research Director(s), the Sr CCQM Lead establishes and/or - local clinical Quality Management System (CCQMs) ... -The role requires the ability to properly oversee and/or lead local quality operations to implement local/regional/global...performs QC activities (incl. QCVs) and conducts ad hoc site visits upon request.-On a regular basis and in… more
- Catalent (St. Petersburg, FL)
- …ensure required actions are completed within the required timeframe Support to Supplier Quality site Teams on routine queries and guidance Manage Supplier ... Supplier Quality Regional Lead Position Summary: Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the… more
- Catalent (PA)
- …pricing and ensure strong connectivity between the various Biologics sites.Assist and/or lead strategic continuous improvement projects at the site to develop ... Proposal Lead I Summary Catalent Biologics is a fast-growing...committed to a Patient First culture through excellence in quality and compliance, and to the safety of every… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Lead Maintenance Technician is a leader with strong interpersonal, communication, and collaboration skills responsible for leads peers in ... supporting the manufacturing process. Individual will possess the ability to lead a team, train others and contribute to and implement process improvements. The … more
- Catalent (Manassas, VA)
- …sourcing and procuring materials, services, and capital for the site . The Site Procurement Manager will lead site procurement team and initiate ... the site and across the company. Leads site -level initiatives for supplier management, supplier quality ...Leads site -level initiatives for supplier management, supplier quality & supplier performance improvement as well as supports… more
- Merck & Co. (Rahway, NJ)
- …degree of technical, project, and people management responsibility. - This SSO Facility Lead role within the SSO Pilot Plant leverages significant depth and breadth ... of scientific, technical, and operational experience to lead and support facility operations, process development activities, compliance investigations/change… more
- Merck & Co. (Durham, NC)
- …our patients. We work in the manufacturing plants with a "Safety First, Quality Always" mindset, striving for continuous improvement, and earn our right to produce. ... local plants connected to our global manufacturing network supplying the highest quality of raw materials, intermediates, and finished products.This role is within a… more
- Merck & Co. (Rahway, NJ)
- …Labeling Therapeutic Area group is to drive labeling strategy and ensure high- quality and compliant labeling documents, which provide the safe and effective use ... Affairs sub-teams to ensure delivery of labeling documents that meet quality and compliance standards and regulatory labeling requirements to support timely… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Tech Unit.- Provides leadership in the project/development team, as Matrix Lead , interfacing with various site locations globally and on ... research areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies within projects, and… more
- Catalent (St. Petersburg, FL)
- …templates and liaise with site and Suppliers to finalize to allow Supplier Quality Director approval Act as a liaison between suppliers and the quality teams ... Quality Auditor Position Summary: Catalent is a global,...during the management of supplier quality issues Lead and support Supplier issues / investigations affecting Catalent… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … and complaint product supply. Key Responsibilities Support compliance activities for site Quality Operations in accordance with Legend standards, procedures and ... based in Raritan, NJ. Role Overview The QA Investigations Lead has the responsibilities for providing quality ...cGMPs Collaborate with site personnel to provide guidance and determine resolution for… more
- Merck & Co. (Durham, NC)
- …sub-team; may manage/ lead a small project teamBasic knowledge of the Quality System Model and relationships across its componentsUnderstands quality systems ... Job DescriptionOur Quality Assurance group ensures every single material inside...working a Hybrid work consisting of three total days on- site per week, generally Tuesday, Wednesday and either Monday… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Lead QC Microbiology Data Reviewer as part of the Quality team based in ... Raritan, New Jersey. Role Overview The Lead QC Microbiology Data Reviewer is an exempt level...program. Maintain, re-evaluate and communicate key critical inputs to site environmental monitoring program. Perform peer review/approval of laboratory… more
- Merck & Co. (North Wales, PA)
- …to Senior Management of the Medical Device and Combination Product (MDCP) Quality Assurance Operations team, the Associate Director Quality Engineering & ... and other worldwide regulations and our Compa requirements.This position provides Device quality engineering and quality assurance support and leadership to… more
- Catalent (Philadelphia, PA)
- Quality Assurance Document Control Supervisor Position Summary Catalent Pharma Solutions in Philadelphia, PA is hiring a Quality Assurance Document Control ... committed to a Patient First culture through excellence in quality and compliance, and to the safety of every...decisions for QADC collectively with the QADC team.Act as site subject matter expert for "Good Manufacturing Practices" and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the CAR-T manufacturing site . Oversee metrics, trending, and reporting of relevant quality systems records. Implement and lead CAPA site governance ... of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Quality Systems Lead role as part of the Quality Operations team based in… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …approval by QA Manager Performs regular internal audits of NNUSBPI facilities as a lead auditor Works closely with Manufacturing and Quality Control to resolve ... About the Department Site New Hampshire, located in West Lebanon, is...to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a… more
- Insmed Incorporated (Bridgewater, NJ)
- …in Design Control Process for medical device products and combination products. Lead the quality assessment for product lifecycle changes, efficiency ... of cGMPs and pharmaceutical manufacturing, Quality Control and Quality Assurance.Commercial drug manufacturing site QA head experience preferredAbility… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and LeadershipHas primary accountability for operational study-level timeline, cost, and quality deliverables. Lead the development of the clinical study plan ... of the CRO scope of work in collaboration with Outsourcing Procurement Management. Lead trial feasibility and site identification activities in collaboration with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …& Leadership Has primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan ... of the CRO scope of work in collaboration with Outsourcing Procurement Management. Lead trial feasibility and site identification activities in collaboration with… more
