- Genmab (NJ)
- …and protocol deviations and is a key driver for inspection readiness , regulatory compliance, and successful data submissions.The Associate Director will lead ... eCOA, biomarkers, imaging).Serve as SME in protocol quality, lab data integrity (central and local), and management...to initiatives that improve operational efficiency, inspection readiness , and regulatory compliance.Act as a Data … more
- 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
- Merck & Co. (Rahway, NJ)
- …operational excellence in the laboratories, and for always maintaining a state of inspection readiness .- The Director should be well engaged with regulatory and ... Products, Cross-Functional Teamwork, Decision Making, Dosage Forms, GMP Compliance, Inspection Readiness , Management Process, Medical Device Management, Medical… 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
- 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
- Lilly (Indianapolis, IN)
- …to the data collected via DnA processes. + Strive to maintain data integrity and inspection readiness to ensure the availability of data as ... and Translation role is accountable for the final delivery of data collection instruments (English/Translations) used in clinical trials. The C/T associate… more
- Lilly (Indianapolis, IN)
- …analytical software is maintained in a validated state and complies with Data Integrity requirements. * Ensure inspection readiness at all times for ... a large change agenda. **Key Responsibilities** * Uphold Lily's values of Integrity , Excellence and Respect for People. Ensure employees maintain all required… more
- Merck (West Point, PA)
- …applicable network teams and communities of practice associated with compliance, facility fitness, inspection readiness , data integrity and other ... Develop and implement comprehensive compliance program for the site to ensure Permanent Inspection Readiness (PIR), which includes leading the site audit program… 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
- Fujifilm (Research Triangle Park, NC)
- …data into the Laboratory Information Management System (LIMS) * Ensures laboratory maintains inspection readiness , data integrity , and Current Good ... with United States Pharmacopeia and European Pharmacopeia * Ability to support audit readiness for the laboratory * Willingness to learn and incorporate lean lab and… more
- Fujifilm (Research Triangle Park, NC)
- …assay or method Subject Matter Expert (SME), as needed + Ensures laboratory maintains inspection readiness , data integrity , and Current Good ... test methods for samples associated manufactured batches + Reviews technical data , authors routine and periodic laboratory reports (eg, Environmental Monitoring (EM)… 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
