- Catalent (Philadelphia, PA)
- …PA is hiring a QA Supervisor. The QA Supervisor will p rovide Quality Assurance support for the Quality Inspectors on the production floor, incoming ... QA Supervisor Position Summary Catalent Pharma Solutions in...material quality , and/or distribution quality , including quality oversight for material management… more
- Catalent (Philadelphia, PA)
- Quality Assurance Document Control Supervisor Position Summary Catalent Pharma Solutions in Philadelphia, PA is hiring a Quality Assurance Document ... 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
- Novo Nordisk Inc. (West Lebanon, IN)
- …compliance with specifications and procedures Releases product based on Quality Assurance record review and approval by QA Manager Performs regular internal ... audits of NNUSBPI facilities as a lead auditor Works closely with Manufacturing and ...leading international regulatory agency preferred As applicable, experience with Quality Assurance oversight and support for all… more
- Catalent (St. Petersburg, FL)
- I. Department Overview: The Quality Assurance Department is responsible for providing leadership and support to the Catalent St. Petersburg site . The ... project to deliver solutions.Collaborates with management and supervisory personnel from operations, quality control and quality assurance to resolve… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … team based in Raritan, NJ. Role Overview The QA Investigations Lead has the responsibilities for providing quality oversight over the production of ... treatment of multiple myeloma. Legend Biotech is seeking a QA Investigations Lead (2nd or 3rd shift)...complaint product supply. Key Responsibilities Support compliance activities for site Quality Operations in accordance with Legend… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the candidate hasexperience working in an aseptic manufacturing facility, preferably in quality assurance ,manufacturing compliance, clinical quality , or cell ... myeloma. Legend Biotech is seeking QA Shop Floor Supervisor as part of the Quality team based in Raritan, NJ. Role Overview The QA Shop Floor Supervisor is… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and supports Supply Chain Management with technical issues post first CPV.Responsibilities- Lead and coordinate the Site -Launch activities and associated teams ... Management (mAb, Drug Substance, Drug Product, or New Modality) Lead is responsible for the management of technology transfer...of the first CPV. The candidate is leading the Site Launch Team with its associated sub-teams. Accordingly, the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …equivalent technical discipline is required A minimum of six (6) years of experience in Quality Assurance / Quality Systems or Compliance with a minimum of 4 ... the treatment of multiple myeloma. Legend Biotech is seeking Quality Compliance Lead as part of the...the planning and execution of internal audits for all quality system areas for the manufacturing site ;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. Summary This position is a Clinical Science lead position and will lead a group of clinical scientists organized ... size of the asset program. This Clinical Science (CS) lead will be responsible for leading and managing one...clinical science perspective, and ensure the writing of high quality clinical trial protocols, review of clinical data and… more
- Merck & Co. (Rahway, NJ)
- …efficient solutions.Define and enforce coding standards, development methodologies, and quality assurance processes.Drive innovation in SAP development ... the EIT SAP Platform Team, the EIT SAP Technology Lead will assume the crucial role of leading all...working a Hybrid work consisting of three total days on- site per week, generally Tuesday, Wednesday and either Monday… more
- Aequor (Thousand Oaks, CA)
- …planned incidents) Represent QA on NPI team) Lead investigations) Lead plant audits, participate in site audits) Approve change-over completion) May ... month - multiple short trips. In support of 's Quality Assurance program manages and oversees the...perform work of QA Specialist EDUCATION/LICENSES Doctorate degree or Master's degree and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …lead of study team lead . Coordinate and liaise with Daiichi Sankyo QA on site audit and inspection activities.Conduct and/or oversee the CRO oversight ... & Leadership Has primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …lead of study team lead . Coordinate and liaise with Daiichi Sankyo QA on site audit and inspection activities.Conduct and/or oversee the CRO oversight ... and LeadershipHas primary accountability for operational study-level timeline, cost, and quality deliverables. Lead the development of the clinical study plan… more
- Merck & Co. (North Wales, PA)
- …We are Looking for: Minimum:-Bachelor's Degree in Regulatory Affairs, Quality Assurance , Clinical Affairs, Pharmacovigilance, Biology, Engineering, Chemistry, ... attend educational sessions, and receive direction from our Veteran Talent Program Lead throughout the Fellowship. Our primary objective is to provide you with… more
- Merck & Co. (Rahway, NJ)
- … quality .Collaborate with cross-functional teams, including operations, maintenance, and quality assurance , to identify areas for improvement and implement ... Eng position will report to the Director, Engineering, Automation Lead position and will be a member of the...working a Hybrid work consisting of three total days on- site per week, generally Tuesday, Wednesday and either Monday… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of concern and either resolve or bring to the attention of the Delivery Lead . Coordinate and liaise with Daiichi Sankyo QA on audit activitiesProvide oversight ... overall study plan provided by the CRO. Participate in site selection and site qualification with (study...functional integration and delivery of items (eCRF, EDC, IXRS, Quality Oversight Plan etc) per the study plan. Oversee… more
- Aequor (Thousand Oaks, CA)
- …leadership, International Quality , Quality Control, Contract Manufacturing Quality , Regulatory, Process Development, Quality Assurance , and other ... for regulatory audits and responses to questions. The individual is directly responsible to lead a Product Quality Team (PQT), including oversight of the product… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Affairs, Sales/Marketing, Managed Markets, Pharmacovigilance, Supply Chain, Compliance, Quality Assurance , pharma-specific litigation issues, promotional brand ... research assigned Compliance cases, develop investigative findings, participate and lead investigative interviews, assist with the drafting of Compliance coaching… more
- Insmed Incorporated (Bridgewater, NJ)
- …substance sections of regulatory filings and dossiers.Sound awareness of Regulatory, Quality Assurance , and cGMP requirementsHigh energy, innovative "can do" ... for being the Technical Operations liaison to the Insmed research team for lead optimization and early development programs. This position will be the dynamic… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and physician scientists as well as external investigators is expectedThe CS Group Lead will also ensure the writing of high- quality clinical trial protocols, ... and people with disabilitiesSummaryThis position will be the Clinical Science Group Lead in late phase development in the Global Clinical Science functionHe/she will… more
