- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for timely and quality delivery and regulatory compliance of outsourced activities.Ensures inspection readiness of all data management activities conducted ... release, data review and cleaning, database lock), to ensure data quality/ integrity and regulatory complianceEnsures that Data Management Plans are… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the supported MA teams, including the quality risk assessments and inspection readiness components for the designated programs.Ensure proactive representation ... in alignment with the business strategy Lead the DSG inspection management activities by ensuring continued submission, compliance and...environment and a cohesive culture driven by values of integrity , respect, and a speak up cultureLead and hold… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Good Practices Guides, and RBA/CSA methodologies to ensure compliance and inspection readiness .Stay current with emerging technologies and industry trends; ... regulations, CSV, 21 CFR Part 11, Annex 11, GAMP 5, and data integrity - Required Deep understanding of IT system architecture, cloud solutions, integrations,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for timely and quality delivery and regulatory compliance of outsourced activities. Ensures inspection readiness of all data management activities conducted ... release, data review and cleaning, database lock), to ensure data quality/ integrity and regulatory compliance Ensures that Data Management Plans are… more
- Kailera Therapeutics, Inc. (Waltham, MA)
- …at Vendors and clinical sites; and collaborating with stakeholders to ensure inspection readiness for assigned programs, laying the foundation for successful ... timely completion of quality assurance activities, including audits, investigations, and inspection readiness . Facilitate review of potential Serious Breach and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with the supported MA teams, including the quality risk assessments and inspection readiness components for the designated programs. Ensure proactive ... portfolios, in alignment with the business strategy Lead the DSG inspection management activities by ensuring continued submission, compliance and inspection… more
- iAnthus Capital (Fall River, MA)
- …site-level quality lead, coordinating cross-functional inspections, managing audit readiness , conducting structured investigations into quality deviations, and ... lead structured root cause analysis and continuous improvement Strong documentation and audit- readiness discipline Benefits: 20 days of accrued Paid Time Off Nine… more
- AbbVie (North Chicago, IL)
- …Facebook, Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Data Integrity Inspection Readiness Lead uses ... audit outcomes. *Develops and executes data integrity campaigns, gap assessments, inspection readiness plans, audit observations and responses, and… more
- V2X (Point Mugu Nawc, CA)
- …of successful mission support to improve security, streamline logistics, and enhance readiness . Aligned around a shared purpose, our $3.9B company and 16,000 people ... here and abroad, to tackle their most complex challenges with integrity , respect, responsibility, and professionalism. **ESSENTIAL DUTIES AND FUNCTIONS:** 1.… more
- Lilly (Indianapolis, IN)
- …+ Support operational and inspection readiness actions related to data management and integrity . + Benchmark with external sources to understand industry ... will be required throughout 2025 and 2026.** **Position Summary:** The Data Integrity Sr. Principal Associate oversees data management activities at… more
- Fujifilm (Research Triangle Park, NC)
- …Performs environmental monitoring of controlled manufacturing environments * Ensures laboratory maintains inspection readiness , data integrity , and ... methods for samples associated manufactured batches * Reviews laboratory testing results and enters data into the Laboratory Information Management System (LIMS) *… more
- Lilly (Pleasant Prairie, WI)
- …of data to drive process improvements. This role ensures compliance and inspection readiness of the data integrity and data management program at ... to drive process improvements. This role ensures compliance and inspection readiness of the data integrity and data management program at the site… more
- Lilly (Pleasant Prairie, WI)
- …+ Create and manage quality master data in SAP including q-info records and inspection plans for materials. + Protect the integrity and accuracy of data ... resolve an issue. + Technical writing and communication skills. + Previous regulatory inspection readiness and inspection execution experience. + Knowledge… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Prepare, test, and implement post-production changes as per study needs while ensuring data integrity + Archive and retire the study URL after database lock ... you to shine? Join us as a Principal, Electronic Data Capture Developer in our Cambridge, MA office. At...to avoid and resolve risks. + Confirm archival and inspection readiness of all Clinical Technology Trial… more
- Bristol Myers Squibb (Indianapolis, IN)
- …systems automation. + Provide IT leadership to site regulatory inspection readiness and data integrity initiatives. + Participate in high-level ... while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. **On-site… more
- Bristol Myers Squibb (Indianapolis, IN)
- …solutions that meet the needs of the site. + Support site regulatory inspection readiness and data integrity initiatives. + Partner on new demand from ... while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. **On-site… more
- Sanofi Group (Framingham, MA)
- …possible. Ready to get started? **Main Responsibilities:** . **Ensure US FDA GMP Inspection Readiness , Inspection Activities, Inspection Follow-Up** for ... and the external network (eg, CMOs, Alliance Partners, etc.): + Enhance inspection readiness through on-site quality system assessments, audits, identifying… more
- J&J Family of Companies (Spring House, PA)
- …the identification, assessment, and mitigation of quality risks that could impact trial data integrity , patient safety, well - being, or rights. Throughout the ... internal procedures, and to maintain a continued state of inspection readiness . **Key Responsibilities** : With supervision... narratives, identify and prepare sites of interest for inspection data (including, pre- inspection visit… more
- Vitesse Systems (Newark, CA)
- …routine programming tasks to support personnel where applicable. + Monitor and improve inspection efficiency, accuracy, and data integrity ; support metric ... new product introduction (NPI) and design-for-manufacturing (DFM) initiatives by developing right-sized inspection plans and ensuring readiness of inspection … more
- Customs and Border Protection (Beecher Falls, VT)
- …Homeland Security by performing law enforcement activities such as inspection , intelligence analysis, examination, and interpretation of laws and regulations. ... of travelers to determine alienage, citizenship, admissibility, and the need for further inspection as well as the physical and visual examination of cargo and… more
