- BioAgilytix (Boston, MA)
- …to GxP guidelines)Essential Responsibilities: Data Review & DocumentationPerform Quality Control (QC) technical and scientific and compliance review of data and ... quality management systemsResponsible for troubleshooting and overseeing resolution of technical issues that arise from the use of the LIMSPlans future workflow… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …role-based training curricula for CMR function to ensure quality and compliance in accordance with ICH/GCP and other regulatory requirements. Collaborate with ... Reports to Associate Director or above within CMR Training & Knowledge Management . Collaborates with global and CMR leaders and stakeholders to develop comprehensive… more
- Novo Nordisk Inc. (Phoenix, AZ)
- …rights and wellbeing; data reliability; scientific integrity; regulatory and process compliance ) for monitoring and site management activities. Takes ownership ... projects for NACD and Novo Nordisk (eg, clinical trial site staff , clinical research vendors). Manages relationships with multiple internal stakeholders relevant… more
- Eisai, Inc (Nutley, NJ)
- …organization's overall security objectives and industry best practices.2. Leadership and management : Lead a team of infrastructure technical security ... will dotted line report into the Global Security & Compliance team (second line of defense). The primary objective...professional development goals can be achieved.3. Identity and Access Management (IAM): Oversee staff in the development,… more
- Merck & Co. (Rahway, NJ)
- …individual to work in a fast-paced job that provides a high degree of technical , project, and people management responsibility. - This SSO Facility Lead role ... to lead and support facility operations, process development activities, compliance investigations/change management , authoring of GMP documentation, and… more
- Merck & Co. (Durham, NC)
- …finances, labor, employee, environment and safetyTactical and strategic Shift(s) management , including collaboration with indirect staff ;Promote the behaviors ... evaluation.- Provide feedback and input on performance evaluations for indirect staff .- Support Talent Management .Direct, coordinate, provide guidance and… more
- Merck & Co. (Rahway, NJ)
- …to work in a fast-paced job that provides a high degree of technical and project management responsibility. The Senior Specialist - Manufacturing Automation ... Facilities Automation Team supporting facility operations, process development activities, compliance investigation, change management and the authoring of… more
- Novo Nordisk Inc. (Boulder, CO)
- …Develops and executes regular surveillance, follow-up, and reporting program to ensure process compliance System Management : Acts as SME and local Super User for ... About the Department The Boulder Site is home to the specialized technical operations/CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a living. Are you ready to make a difference? The Position To ensure compliance with all Federal regulations and company SOPs regarding safety reporting from both ... US marketed products (drugs and devices). To support workflow management and coordination of all daily operations of Product...and devices). To contribute and support activities related to compliance reporting and quality tasks in order to ensure… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …ability to effectively collaborate with a broad variety of executives, scientific leaders, technical staff , administrative support staff , and all other ... & Mentorship: Manage and mentor a team of Principal Investigators and associated technical support staff . Foster an environment of innovation, collaboration and… more
- BioAgilytix (Durham, NC)
- …right at home here at BioAgilytix.Essential ResponsibilitiesPerform Quality Control (QC) technical , scientific, and compliance review of data and documentation ... of our beginning-to-end client data quality processes. Through your technical reviews of raw and processed data, you will...QC review observations and work closely with the scientific staff to ensure data integrityCollect metrics data used to… more
- Merck & Co. (Rahway, NJ)
- …to work in a fast-paced job that provides a high degree of technical and project management responsibility. The Specialist -Engineering position will report ... the Company's pipeline. This role may support facility operations, support compliance investigations/change management , author GMP documentation and manage/lead… more
- Catalent (St. Petersburg, FL)
- …Manager may oversee a staff from five to ten including Sr QA Technical Reviewers and QA Product Managers. Responsible for ensuring the site is following cGMP ... Assurance Department is responsible for providing Leadership and Quality Assurance Management support within at Catalent's St. Petersburg site. The Department has… more
- Eisai, Inc (Nutley, NJ)
- …in implementing and maintaining robust cybersecurity practices, including risk management , access controls, network security, and compliance , is ... Security, and provide leadership to managed services vendors. Organizational management responsibilities include resource prioritization, alignment with the CIO… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …rights & wellbeing; data reliability; scientific integrity; regulatory & process compliance . Takes ownership to deliver upon near-term North America Clinical ... projects for NACD and Novo Nordisk (eg, clinical trial site staff , IRBs, clinical research vendors). Manages relationships with multiple internal stakeholders… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ensure compliance with contract expectations Understands & Applies Risk Management Practices: Ensures system design adheres to compliance requirements, SOX ... broad range of expertise of principles, methods, practices, standards, procedures and compliance requirements of the business function in designing and developing IT… more
- Merck & Co. (Durham, NC)
- …personal integrity, credibility, and energy Strong planning, scheduling, and time management skills- Experience in Operations, Quality, Technical Operations, ... comprehensive technology transfer of the HPV vaccine manufacturing process while ensuring compliance with all regulatory and safety guidelines. Lead a diverse team… more
- Merck & Co. (Baton Rouge, LA)
- …breakdown, duration of the work, resources required, etc.).Organizes work in compliance with safety rules.Drafts work orders.Enters information in the MP2 ... (computerized maintenance management system).Makes production reference changes on sensitive equipment.Follows applicable methods and procedures.Advises on and… more
- Aequor (Thousand Oaks, CA)
- …Supply Chain Description: Candidates will, under limited supervision and in compliance with clinical regulatory requirements, partner with key stakeholders to manage ... Planners and Logistics Service Providers - Partner with clinical site staff and Quality to document, investigate, and communicate decisions concerning distribution… more
- Merck & Co. (Rahway, NJ)
- …of a global programming team that includes outsource provider staff .Membership on departmental strategic initiative teams.Position Qualifications: Education Minimum ... & development (R&D) projects (data, analyses, tables, graphics, listings).Strong project management skills; leadership at a program level; determines approach and… more
