- Merck & Co. (Rahway, NJ)
- …of GMP Compliance will report to the head of the Global Quality Compliance Support organization.- The responsibility of this position crosses all Human ... and research services to global QMS topic owners and site quality experts to assess the compliance impact of potential updates to our company's policies and… more
- Merck & Co. (Rahway, NJ)
- …challenges, balancing effective operations with transformative initiatives.- The Associate Director, Quality System & Compliance will support to integrate the ... Project Plan for each MDCP Program (with target dates) for execution.Leads Quality / Compliance Risk Assessments including Quality Risk Management Plans,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Quality and Integrity (Global R&D & PV QA) ensures high standards of data quality and compliance within Global R&D & PV QA. This role leads cross-functional ... on the creation of Corrective and Preventive Actions (CAPA) to ensure compliance and improve data quality . Compliance and Quality OversightPlay a key… more
- Merck & Co. (Durham, NC)
- …operational challenges.Decisions are guided by policies, procedures and/or business plans.Provides quality and compliance guidance to employees, colleagues or ... produce life-saving medicines and vaccines, including our HPV vaccines.DescriptionThe Quality Associate Specialist provides guidance/direction on the shop floor… more
- Beckman Coulter Diagnostics (Miami, FL)
- …suppliers to develop and implement robust risk mitigation plans addressing quality , compliance , and supply continuity risks.Collaborate with cross-functional ... standards, including ISO 13485, 21 CFR Part 820, and other applicable quality and compliance frameworks.The salary range for this role is $155k - $200k,… more
- Tris Pharma (Monmouth Junction, NJ)
- …and Preventative Actions (CAPAs) and Continued Process Improvements (CPIs), Product Quality Complaints (PQC) documentation, compliance efforts, quality ... degree in science or related field and minimum 6 years quality and/or cGMP compliance experience in the pharmaceutical or biotechnology industry in positions of… more
- Cepheid (Miami, FL)
- …to identify and implement improvements. This position will work with the Senior Manager Quality Systems Compliance .This position is part of the Quality ... Device Single Audit Program (MDSAP) participating regulatory authorities Provide cross-functional compliance support for global QMS and Intracompany Quality … more
- Beckman Coulter Life Sciences (Indianapolis, IN)
- …procedures. Influences interpretation of internal policies and procedures to ensure quality and compliance .The essential requirements of the job include:Degree ... about the Danaher Business System which makes everything possible.The Staff Quality Assurance Engineer or Scientist is responsible for facilitating application of… more
- BioAgilytix (Durham, NC)
- …a foundational data governance framework, with hands-on responsibility for data quality , access control, and compliance protocols.Define standards, build ... with a focus on operational efficiency and data integrity. Data Quality & Compliance Automation: Use Robotic Process Automation (RPA) tools like UiPath or… more
- Merck & Co. (Rahway, NJ)
- …compliant, collaborative, and innovation-focused work environment.Builds a culture of quality and compliance through training, oversight, and ... and execution (prioritizing programs, working with Key Opinion Leaders (KOLs), etc.). Quality / Compliance Adherence / Standard:Ensure that compliance… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …functional understanding of cGMPs, established manufacturing practices and procedures, and compliance with Quality regulations and guidelines o Ability to ... The Position This position has primary responsibility to support operations for Quality Control. Assists in coordination and execution of process and equipment… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …resolutionProactively ensure that all functions consistently operate in a state of compliance .Facilitate the implementation of the quality strategy in close ... of respective product profile to ensure appropriate management review of all quality and compliance related topics including the review of Key Quality … more
- Novo Nordisk Inc. (West Lebanon, IN)
- …strict adherence to cGMPs, established manufacturing practices and procedures, and compliance with quality regulations and guidelines. This position carries ... your potential? The Position This position has primary responsibility to support Quality Control operations in the microbiology, analytical or inspection area. This… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …requires strict adherence to cGMPs, established manufacturing practices and procedures, and compliance with quality regulations and guidelines. This role is ... onsite based Monday through Friday, during standard office hours at our West Lebanon, NH bioproduction facility. Relationships Reports to: QC Supervisor Essential Functions Performs routine QC support activities (eg housekeeping, sanitizations, glassware… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …team will consist of managing external resources and some internal resources.Ensure safety, quality , and compliance is the main goal for all new and ... the qualification activities are performed within an appropriate level of GxP compliance . This individual will need to build strong partnerships with Engineering and… more
- Merck & Co. (Rahway, NJ)
- …Region, Regional Country and - Cluster Directors, and their respective staff. Ensure that compliance , quality and timeline - objectives are met for all trials ... Quality Assurance (QA) - group and the Good Clinical Practice Quality and Compliance Council (GCP QCC). Represent GCTO and the Regions on strategic… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …that would provide reduction in COGs, increase throughput, capacity and quality compliance .Build strong partnerships with Manufacturing, Engineering and ... to address and resolve manufacturing issues.Key Responsibilities Partner closely with Quality , Compliance , and technical experts to drive accelerated, robust,… more
- Merck & Co. (Rahway, NJ)
- …assessing, and mitigating potential risks to ensure patient safety and product quality .Ensure compliance with all regulatory requirements and quality ... objectives for launch preparedness and enhanced robustness, regulatory, and compliance requirements of the company.Provide executive leadership and direction for… more
- Merck & Co. (Rahway, NJ)
- …for sustained launch in alignment with the company's business goals, and quality and regulatory compliance . Essential Duties and Responsibilities: Program ... needs.Build strategic partnerships with manufacturing sites and partner groupsRegulatory Compliance and Quality Assurance:Ensure that all activities are… 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
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