- Tris Pharma (Monmouth Junction, NJ)
- …(PQC) documentation, compliance efforts, quality operations, etc. Responsibilities:Assures compliance with all SOPs, cGMP, FDA , as well as all applicable ... work experience:Bachelors degree in science or related field and minimum 6 years quality and/or cGMP compliance experience in the pharmaceutical or biotechnology… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Title -Director/ Principal Scientist, Regulatory Compliance Department - Device Quality & Regulatory Brief Description of Position- This ... and analysis of data for management review. Reports to - Director Regulatory Compliance , Device Quality and Regulatory Location - Remote, Preference would be… more
- Merck & Co. (Upper Gwynedd, PA)
- …and result in outcomes that demonstrate the Company's commitment to regulatory compliance .Ensures that a cross-functional team (eg Quality & Continuous ... level sites that require headquarters input. Other Responsibilities Provides input into GCP Quality and Compliance Council regarding the Quality Management… more
- Merck & Co. (Rahway, NJ)
- …and Continuous ImprovementDevelop and implement continuous improvement strategies for device quality and regulatory processes.Monitor and ensure compliance with ... pipeline and regulatory strategy.Drive operational excellence initiatives that improve quality , compliance , and organizational efficiency.Liaise with external… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Procedures, Work Instructions, Deviations, and other quality documents for cGMP compliance and consistency with FDA regulations. Aiding members of the ... essential to an effective functioning of the various subunits of the Quality System and ensuring accountability. Achieving compliance with cGMP and… more
- Merck & Co. (Durham, NC)
- Job DescriptionResponsibilities: Responsible for the quality aspects of good manufacturing practices (GMP) computerized systems and the supporting infrastructure ... facilities, utilities, manufacturing, packaging, labeling, and laboratories to ensure compliance with company policies, procedures, and regulatory expectations. Be… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … compliance with Service Level Agreements (SLAs) and Pharmacovigilance Agreements (PVAs) Compliance With FDA and Health Canada Reporting Regulations & Audits: ... Product Quality : Oversees the implementation of procedures to ensure compliance with Good Manufacturing Practice (GMP) with respect to technical complaint… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Procedures, Work Instructions, Deviations, and other quality documents for cGMP compliance and consistency with FDA regulations. Aiding members of the ... System and by ensuring accountability for the efficient execution of critical quality tasks. Fostering efficiency, maintaining compliance with cGMP and other… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Responsibilities Support and lead continuous improvement projects.Managing people to support Quality improvement initiatives.Provide quality and compliance ... productivity, as well as broadening technical and scientific knowledge.Detailed knowledge of Quality and Compliance standards. Key Relationships: Works in a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling documentation.Establishes ... tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything ... reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI products. This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global QMS to build a phase appropriate quality system that supports quality and compliance of Good Clinical Laboratory Practices and Good Laboratory ... duties under the RDPV QA function to ensure that Quality assurance oversight are being addressed and managed appropriately....Practices. Proactively identifies compliance risks impacting research unit across DSG, and assures… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …documents (eg, clinical overviews, formulary dossiers, online evidence repository). Ensure compliance with FDA requirements as they affect medical ... interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … compliance .Must have a strong knowledge and experience with cGMP, GCP, GLP, Quality and Compliance .Must have strong authorship and be able to critically ... our company regulations and other global health authority regulators such as FDA . Will collaborate cross functionally to close nonconformance records and identify… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will recommend, own, and implement corrective/preventative measures aimed at improving compliance and reducing repeat occurrences ensuring consistent quality ... requested.Identify and implement process improvements related to safety, environmental, quality , compliance , productivity, yield, and cost.Implement process… more
- Tris Pharma (Monmouth Junction, NJ)
- …builds in-house analytical capabilities, when needed. The incumbent ensures timeline, quality and compliance with applicable Standard Operating Procedures ... packages per International Council for Harmonization (ICH)/Food and Drug Administration ( FDA ) guidance and provides technical guidance within and outside R&D for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes ... Independently leads cross functional teams through all labeling discussions with the FDA /CHMP while ensuring management alignment. Strategizes and plans for FDA … more
- Aequor (Bothell, WA)
- …Cycle, and Good Documentation Practices.Comprehensive knowledge of SOPs, cGMPs, and other compliance requirements and regulatory guidelines ( FDA , EU) and the ... support in our Digital Plant organization working to support, enhance, and maintain compliance for the GxP benchtop systems and instrumentation as well as site and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … quality indicating data and identifying trendsProvide oversight for trending of quality compliance metricsWork in a collaborative team setting with ... projects, and tracking of quality metrics while ensuring high quality and complaint product supply.Key ResponsibilitiesSupport compliance activities for site… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance , clinical quality , or cell ... a QA Shop Floor Supervisor as part of the Quality Operations team based in Raritan, New Jersey. Role...leadership experience is also required.Knowledge of cGMP regulations and FDA /EU guidance related to manufacturing of cell based products… more
