- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Head of Compliance as part of the Global Quality team based in Raritan, NJ. ... a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop...Role OverviewThe Head of Compliance will be responsible for providing quality … more
- Insmed Incorporated (NJ)
- …alignment with business objectivesCollaborate closely with cross-functional teams including Quality Assurance, IT, CSV, and Compliance departmentsEnsure that ... as the IT System Owner for the Learning Management System and compliance IT systems, which includes supporting GxP-regulated applications, while also functioning as… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and Preventive Actions (CAPA) process and is responsible for ensuring compliance within quality systems processes.Key Responsibilities Provide oversight to ... systems records.Support CAPA site governance programDrive continuous improvement of quality systems processes.Ensure compliance with current Good Manufacturing… more
- Merck & Co. (Rahway, NJ)
- …and drug product container closure systems including mold qualification and regulatory compliance .- To act as master data stewards and support enterprise wide ... shooting and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across the internal and external… more
- Merck & Co. (Rahway, NJ)
- …for new and commercial human health products including active pharmaceutical ingredients, drug substance, drug product, finished goods including combination ... teams and stakeholders to ensure that all platforms meet safety, efficacy, quality , and robust supply standards. Develop and maintain strong relationships with… more
- ValSource, Inc. (Rahway, NJ)
- …that pharmaceutical manufacturing processes and systems meet regulatory and quality standards. This role involves extensive travel to various client locations, ... EPCMV, Quality by Design and risk-and science-based approaches for compliance are desired. Experience with system and process risk assessments; including FMEA,… more
- Merck & Co. (Rahway, NJ)
- …for new and commercial human health products including active pharmaceutical ingredients, drug substance, drug product, finished goods including combination ... and maintain strong relationships with internal stakeholders, including commercialization, quality , analytical, regulatory, manufacturing, and Supply Chain to facilitate… more
- Merck & Co. (Rahway, NJ)
- … Quality Control, Master Batch Records, Material Selection, Pharmaceutical Process Development, Production Planning, Regulatory Compliance , Shift ... of PAS-X is preferable.GMP: Follow established inspection batch records, protocols and quality standards to ensure compliance with industry regulations.- Able to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... understanding of CMC principles, strategies, and processes: Understand regulatory compliance /requirements of manufacturing clinical and commercialization products. Support Tech… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of experience in documentation management, quality assurance, or regulatory compliance within the pharmaceutical or biotechnology industry Strong knowledge ... a strong background in documentation management, process oversight, and regulatory compliance within the pharmaceutical or biotechnology industry. Relationship… more
