- Novo Nordisk Inc. (Plainsboro, NJ)
- …in compliance with local and federal regulations (21 CFR FDA Post-Marketing), global/local SOPs, and other governing standards Maintains proficient understanding ... 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ensuring highest quality to patients. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to ... applicable Develops comprehensive, relevant resources (eg training program, FAQs) to enable compliance with quality control process requirements across NNI and… more
- Repligen (Waltham, MA)
- …growing Supplier Quality team. You will a key role in ensuring the quality , compliance , and performance of Repligen's global supplier base. This is an ... Notifications (SCNs)Evaluate and manage Supplier Change Notifications to ensure compliance with internal and regulatory quality standards.Coordinate… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....chain and customer focus. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for ... design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the … more
- Aequor (Cincinnati, OH)
- …needed Monitoring chemical and dry stock inventory Assist with ordering chemicals/materials COMPLIANCE AND QUALITY Basic knowledge and understanding of USP, ... Quality Control Analyst I Does the position allow for the...cGMP, and FDA regulations Create and maintain lab record documentation (notebooks and computer… more
- Merck & Co. (Rahway, NJ)
- …in the US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to stakeholders ... (Research & Development) by:Developing an active engagement strategy with US FDA and global health authorities to advocate advanced regulatory strategies for… more
- Twist BioScience (South San Francisco, CA)
- …analytics, and data visualization capabilities to support operational decision-making and quality reviews. Compliance & Validation: Ensure our custom MES ... across our biomanufacturing operations. This critical role will drive efficiency, quality , and robust data integrity within a highly automated environment. The… more
- Merck & Co. (Rahway, NJ)
- …Python Programming for SDTM Conversions.Demonstrated success in the assurance of deliverable quality and process compliance .Excels in technical writing, able to ... global human health.Responsibilities: The Senior Statistical Programmer, Submission Data Standards Quality Management (SDS QM), provides oversight and quality … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …systems auditing program fulfills regulatory requirements performs audits, identifies compliance issues and trends, reviews systems and procedures.Ensure trending ... for risk mitigation.Support the stakeholders in identifying and defining quality improvement initiatives for development activities / programs post internal… more
- Tris Pharma (Monmouth Junction, NJ)
- …control systems to maintain optimal stock levels and minimize obsolescence; Ensures compliance with safety, quality , and regulatory standards in warehouse ... supplier relationship management, procurement systems functionality/workflows and assurance of compliance with GxP and other company and regulatory agency… more
- Aequor (Hicksville, OH)
- …employees. Adheres to all applicable procedures, cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA , EMEA, ANVISA, HS&E, ... etc.). Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory ( FDA , DEA, OSHA) standards, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …teams, manage performance, and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA , EMA, and ... size.Responsible for multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics; these metrics will… more
- BioAgilytix (Durham, NC)
- …a foundational data governance framework, with hands-on responsibility for data quality , access control, and compliance protocols.Define standards, build ... between systems, with a focus on operational efficiency and data integrity. Data Quality & Compliance Automation: Use Robotic Process Automation (RPA) tools like… more
- Merck & Co. (Rahway, NJ)
- …knowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA ... set tactical and strategic direction on programs to ensure delivery of high- quality products, test methods, and robust manufacturing processes for both clinical and… more
- Merck & Co. (Rahway, NJ)
- …controls areaKnowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA ... Development and with external suppliers.Understand and apply regulatory / compliance requirements relative to design controls and risk management activities.Lead… more
- Aequor (Hicksville, OH)
- …employees. Adheres to all applicable procedures, cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA , EMEA, ANVISA, HS&E, ... is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory ( FDA..., DEA, OSHA) standards, and Departmental, Plant, and Corporate quality and Behavioral Based Safety (BBS) goals. Note: This… more
- Aequor (Hicksville, OH)
- …occur. Adheres to all applicable procedures, cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA , EMEA, ANVISA, HS&E, ... etc.). Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory ( FDA , DEA, OSHA) standards, and… more
- Tris Pharma (Monmouth Junction, NJ)
- …and advances required documentations, in liaison with Product Development (PD)/ Quality Assurance (QA)/ Quality Control (QC)/Regulatory Affairs, including ... Executes studies and prepares technical protocols/reports in response to FDA Information Requests (IRs)/Complete Response Letters (CRLs)Cleans, maintains and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance , GCP/Document Audits supports end-to-end audit activities per audit program of ... provide inspection management support and follow-up activities post inspection regarding compliance commitments are fulfilled on time and that evidence is… more
