- Repligen (Waltham, MA)
- …Join us!IT Manager , SOX & ITGC ComplianceWe are seeking an experienced IT Manager , SOX & ITGC Compliance to lead the design, implementation, and ongoing ... across ITGC and SOX processes.Utilize data analytics to enhance testing quality , reduce risk, and improve audit coverage.Stay current on regulatory requirements… more
- Genmab (NJ)
- …(SDTM) standards that support the scientific need of a study/program while ensuring quality , consistency and compliance to CDISC standards and other industry ... fit? Then we would love to have you join us!The RoleThe Senior Manager , Clinical Programming is responsible for the establishment, governance, and integrity of Study… more
- MCKESSON (Richmond, VA)
- …deployment using Infrastructure-as-Code tools like Terraform, Azure ARM Templates, and GCP Deployment Manager . Collaborate with cross-functional teams, mentor ... healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with CRO/ vendors/ site/ country performance raised by the study team, including serious quality incidents and serious breaches of GCP . The SDL is accountable ... issues with CRO/ vendors/ site/ country performance including serious quality incidents and serious breaches of GCP ....performance and management of 3rd party vendors to ensure compliance with Daiichi Sankyo's quality measures and… more
- Formation Bio (New York, NY)
- …clinical programs across various therapeutic areas and phases (I-IV), ensuring compliance with global regulations, delivering on timelines and budgets, and driving ... forecasts, and resource allocation. Ensure all clinical trials comply with ICH- GCP , FDA regulations, and other applicable regulatory standards. Champion proactive… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …to help shape how regulated processes are managed across Global Development. As Manager , GDQTC, you'll support our Veeva Quality Suite-based eQMS _which manages ... ownership with system-level thinking-driving meaningful improvements in how we maintain GCP and GVP compliance across Regeneron's global development operations.… more
- Capital One (New York, NY)
- Sr. Manager , Solutions Architect ( GCP , AWS) Capital One is seeking a highly skilled Solutions Architect to join our exceptional team of talented technologists. ... and deploying solutions for a large-scale migration project, transitioning a current GCP environment to a robust AWS cloud infrastructure. The ideal candidate will… more
- Huntington National Bank (Chicago, IL)
- Description Role Overview / Summary + The Sr Engineering Manager will serve as the opinion leader and accountable owner for the strategic Enterprise Query Hub (EQH) ... platform on Google Cloud Platform ( GCP ). EQH is the operational data store that consolidates...plans, risks, and outcomes to business, technology partners, and risk/ compliance stakeholders. + Operational data store design: Own data… more
- Takeda Pharmaceuticals (Boston, MA)
- …Takeda Development Center Americas, Inc. is seeking a Clinical Program Quality Manager with the following duties: Support GCP compliance activities for ... teams and quality functions to identify and mitigate systemic GCP compliance issues across oncology programs; analyze and report compliance metrics… more
- Dartmouth Health (Lebanon, NH)
- … Quality & Safety, provides coordination for the administration, support, quality assurance, and management of research compliance functions for Dartmouth ... quality assurance activities, training and education on research compliance topics, and supports institutional policy and procedure development. Responsibilities… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- **Job Description Summary** The Sr. Manager , Clinical Quality serves as a key leader within the Medical Affairs organization, responsible for overseeing a team ... dedicated to ensuring regulatory compliance , Good Clinical Practice ( GCP ), subject safety,...**maker of possible** with us. **Job Summary:** The Sr. Manager , Clinical Quality serves as a key… more
- HCA Healthcare (Nashville, TN)
- **Description** **Introduction** Do you have the career opportunities as a Manager , Data Quality you want with your current employer? We have an exciting ... expertise! **Job Summary and Qualifications** Job Summary The Data Quality (DQ) Manager within the Data Office,...Quality , RDM, and governance on Google's Cloud Platform ( GCP ). + Consult on deep dives into extremely complex… more
- IQVIA (Durham, NC)
- …teams, customer and other stakeholders in a joint effort to adopt the Quality Plan, Standard Operating Procedures (SOPs), improving compliance to International ... key stakeholders on all aspects of Good Clinical Practice ( GCP ) compliance . * Work in close cooperation...* Work in close cooperation with teams to manage non- compliance , quality issues, support in planning corrective/preventive… more
- ThermoFisher Scientific (Wilmington, NC)
- …Demonstrated ability to use critical thinking is required. At least 2 years in Clinical Quality , GCP Compliance or related is preferred. Experience in CAPA, ... **What will you do in this role?** Develops and executes quality and compliance strategies and initiatives across the organization, including promoting awareness… more
- ThermoFisher Scientific (Morrisville, NC)
- …Overview** Lead internal audits at Thermo Fisher Scientific as an Audit Manager . Ensure compliance with global regulations. **Key Responsibilities** Internal ... centered on risk management for GxP domains (GMP, GLP, GCP , GDP, etc.) that aligns with corporate quality...+ Periodically adjust the plan based on emerging risks, compliance history, regulatory updates, and business priorities. + Conduct… more
- Confluent (Des Moines, IA)
- …Role:** We are seeking a highly experienced and technically proficient **Staff Risk & Compliance Program Manager (Insider Threat)** to join our Trust & Security ... time, within budget, and to a high standard of quality . **Engineering Partnership:** Act as the primary liaison between...alert on anomalous or high-risk user behavior. **Policy and Compliance :** Partner with Legal and HR to ensure all… more
- Abbott (Minnetonka, MN)
- …people to restore their health and get on with their lives. As the Senior Manager Quality Engineering, you'll provide leadership and guidance for the quality ... medicines. Our 114,000 colleagues serve people in more than 160 countries. **Senior Manager , Quality Engineering -- Minnetonka MN** **Working at Abbott** At… more
- ARTIDIS (Houston, TX)
- …visits (site initiation and training, monitoring, and close-out) following national regulations, GCP , and quality standard operating procedures as set out in ... designed and supervised directly by ARTIDIS. The Clinical Study Manager is an integral part of the Clinical Operations...he/she is responsible that the study conduct is in compliance with the approved study protocol and Good Clinical… more
- Mount Sinai Health System (New York, NY)
- …resources and allocate tasks to ensure timelines and objectives are met. **Regulatory Compliance and Quality Assurance:** + Ensure all trials adhere to Good ... **Job Description** The **Project Manager II** will oversee the entire portfolio of...Develop and implement best practices to enhance efficiency, data quality , and compliance . + Monitor industry trends… more
- Astellas Pharma (Dallas, TX)
- …and activate the site in the shortest possible timeframe. + Ensure site compliance with study protocol, ICH- GCP , and local/country regulations. + Ensure ongoing ... **Clinical Site Manager - TX** Do you want to be...assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating… more
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