- Insmed Incorporated (San Diego, CA)
- … systems .2+ years' in a managerial role with people/project oversight .5+ years' experience developing and managing projects budgets and forecasts.Experience ... plans, requirements, testing documents and summary reports.Familiarity with cloud-based systems and SaaS validationExperience managing oversight of multiple… more
- Insmed Incorporated (NJ)
- …a key team member. Provide guidance and support to ensure Insmed computerized systems are deployed following lifecycle management and remain in a validated state (eg ... security requirements. \tEnsure compliance and operational efficiency of validated systems through participating in release management, change control, periodic… more
- Syner-G BioPharma Group (Boston, MA)
- …and oversee emergency troubleshooting and repair on various HVAC, mechanical, utility systems , and lab and manufacturing equipment ( GxP and non- GxP ... strategic guidance and hands-on expertise to streamline operations, enhance quality systems , and ensure regulatory compliance, empowering our clients to navigate… more
- Bristol Myers Squibb (Devens, MA)
- …+ Accountable for the performance/delivery of the QASF quality organization, including oversight of the QA on-the-floor systems and programs that enable ... mindset and ability to create innovative solutions. + Demonstrated experience working with GxP electronic systems such as Manufacturing Execution Systems … more
- ThermoFisher Scientific (Waltham, MA)
- …service providers. + Practical familiarity with ERP, MES, QMS, LIMS, or Supply Chain systems . + Solid understanding of GxP and data integrity requirements. + ... to push global advancements in health, cleanliness, and safety as a Sr. IT Program Manager in Waltham. Become a part of our elite team, guiding ambitious IT projects… more
- Gilead Sciences, Inc. (Foster City, CA)
- …participating in evaluation and feasibility analysis for new or updated systems or applications. Post-implementation, you will conduct thorough reviews to assess ... value-driven prioritization, quality governance, and compliance. The IT Business Capability Manager - Technical Development (Process Development) in the PDM IT… more
- ThermoFisher Scientific (Morrisville, NC)
- …Lead internal audits at Thermo Fisher Scientific as an Audit Manager . Ensure compliance with global regulations. **Key Responsibilities** Internal Audit Planning ... & Oversight + Create and uphold an Annual Internal Audit Plan centered on risk management for GxP domains (GMP, GLP, GCP, GDP, etc.) that aligns with corporate… more
- Bristol Myers Squibb (Devens, MA)
- …+ Accountable for the performance/delivery of the QA field quality organization, including oversight of the QA on-the-floor systems and programs that enable the ... role on the Shop Floor Quality Assurance team. As ** Manager , Shop Floor Quality Assurance, Cell Therapy** , you...based on target audience. + Demonstrated experience working with GxP electronic systems such as Manufacturing Execution… more
- PCI Pharma Services (Madison, WI)
- …our global network to pioneer and shape the future of PCI. The Senior QA Manager will work with other departments to ensure the quality of products and compliance to ... and external standards. The role supports and provides quality oversight of the day-to-day operations of the Madison, WI...opportunity exists for the incumbent to shape and transform GxP programs by providing QA expertise and guidance to… more
- Teva Pharmaceuticals (West Chester, PA)
- …through performance fundamental chemical, physical and structural testing within a GxP -compliant QC laboratory to support preclinical and clinical production as well ... lab testing, and regulatory submissions. The incumbent may also participate in/provide oversight of activities related to the management of CGMP analytical method… more
