- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting GxP and Non- GxP activities, assuring that these systems are compliant ... questions and issues.Responsibilities- Provide Validation Lead support for Daiichi Sankyo GxP and Non- GxP computer systems implementations in partnership with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …resolution of issues.Lead effective communications within the GPT, by interacting with other GxP QA functions (GMP/ IMP QA, Audit Compliance, Quality Management ... System [QMS] QA, PV/MA Quality) and in close collaboration with CAPA Manager .), on GxP topics/issues impacting the respective clinical programs.Help to ensure in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …but not limited to the following: all units in Patient Safety, NNI GXP Support, NNI Legal, NNI Compliance, NNI Commercial, NNI Finance, Global Business Services ... SDEA templates meet both Global and local regulatory requirements Supports audit and inspection readiness Develops and maintains company (safety) SOPs Business… more
- Regeneron Pharmaceuticals (Troy, NY)
- We are currently looking to fill a Manager , Quality Auditing (Post Audit ) position. This position is responsible for providing professional expertise, ... CAPAs, and provides leadership and supervision to GMP Auditing Post- Audit Team personnel; promotes a GxP and...industry, including experience with Quality Systems and auditing: + Manager - 7+ years + Sr Manager … more
- Danaher Corporation (Fargo, ND)
- Audit Manager , Regulatory Affairs & Compliance...inspections (FDA, MHRA, EMA, etc). + Qualified as an Quality/ GXP Auditor by a third party. At Danaher we ... Manage and host client audits to ensure that client audit needs and expectations are met and that Aldevron...lead, perform/host, and closeout client audits. + Present each audit observation to site leadership in recurring Review Boards.… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting GxP and Non- GxP activities, assuring that these systems are compliant ... and issues. **Responsibilities** - Provide Validation Lead support for Daiichi Sankyo GxP and Non- GxP computer systems implementations in partnership with Global… more
- ThermoFisher Scientific (Greenville, NC)
- …within the environment. + Collaborate with IT and compliance teams to ensure GxP guidelines are followed, including data integrity, audit trails, and ... Major Incident Management events, Quality, Regulatory, or Sarbanes-Oxley (SOX) audits. GxP regulatory support and customer-specific data delivery. + Provide direct… more
- Editas Medicine (Cambridge, MA)
- …are leading the way towards a healthier and more equitable future The Manager , Quality Compliance, is responsible for Audit Management and Inspection Readiness. ... position will facilitate and monitor the life cycle of audit findings until completion. The Manager , Quality...exercises + Lead and support the preparation activities for GxP Compliance audits and Health Authority Inspections as needed.… more
- ThermoFisher Scientific (Wilmington, NC)
- …based role, but requires some travel **Discover Impactful Work:** As a Compliance Manager within the Quality Investigation and Support team, you will lead complex, ... strategies to address issues. You may perform technical document review and other GxP activities in support of project work or company process. This role plans… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …of issues. + Lead effective communications within the GPT, by interacting with other GxP QA functions (GMP/ IMP QA, Audit Compliance, Quality Management System ... [QMS] QA, PV/MA Quality) and in close collaboration with CAPA Manager .), on GxP topics/issues impacting the respective clinical programs. + Help to ensure in… more
- Cambrex High Point (Durham, NC)
- …career where You Matter by applying today! Job Overview The QA Compliance Manager is responsible for the inspection readiness program for the assigned site. ... agency or client audits. Accountable to the client and/or agency for audit observations responses and the associated corrective measures. or GMP/GDP audits (for… more
- Frontier Medicines (Boston, MA)
- Join us as the Senior Manager /Associate Director of Quality Assurance at Frontier, where precision meets purpose. In this pivotal role, you'll oversee GCP/GLP ... improving product quality. + Implementing process improvements required to ensure GxP compliance in early clinical development environment with strategic view toward… more
- Church & Dwight Co., Inc. (Mason City, IA)
- …NC Root Cause Analysis / CAPA + Validation + Supplier oversight/CAPA + Document control + GxP + Audit program + KPI/CSD/goal metrics + Cost of Poor Quality + ... Have the Power to Win. Job Title: SPD Quality Manager Role Summary Responsible for ensuring the overall site(s)...KPI. + Manage and communicate out on all site audit schedules, ensure teams are adequately prepared, and provide… more
- IQVIA (Columbus, OH)
- …& coordinate assigned QA program in support of customer accounts, functional accounts, audit and inspection program, or QA quality management system at a regional ... activities of Quality services, results of activities, quality initiatives, GXP etc.** Ensure the follow-up of major and critical... etc.** Ensure the follow-up of major and critical audit findings to ensure that appropriate actions have been… more
- CBRE (Charlotte, NC)
- Quality & Compliance Manager - onsite Job ID 151569 Posted 24-Jan-2024 Service line GWS Segment Role type Full-time Areas of Interest Facilities Management, Risk ... - United States of America **ABOUT THE ROLE** As the Quality & Compliance Manager , your primary responsibility is to oversee and ensure all operations align with… more
- United Therapeutics (Durham, NC)
- …improvement + Support clinical team in preparing for external audits + Facilitate GXP Compliance/QA audit activities for clinical development to include root ... continuing education based on findings from oversight activities + Collaborate with GXP Compliance/QA to identify trends resulting from GXP Compliance/QA audits… more
- J&J Family of Companies (Raritan, NJ)
- CMDB & Discovery Senior Product Manager - 2406185467W **Description** Johnson & Johnson is recruiting for a CMDB & Discovery Product Manager located in Raritan, ... opportunity to join our team as the Global CMDB & Discovery Product Manager . We are seeking a versatile and transformative individual who is passionate about… more
- Glenmark Pharmaceuticals Inc., USA (Mahwah, NJ)
- Associate Manager , Transportation and Analytics Department: Operations Location: Mahwah, NJ START YOUR APPLICATION ... (https://apply.hrmdirect.com/resumedirect/ApplyOnline/Apply.aspx?req\_id=3010031&source=3010031-CJB-0) POSITION DESCRIPTION Role / Position Title - Associate Manager , Transportation and Analytics Department/Function - Operations Country -… more
- Sanofi Group (Bridgewater, NJ)
- **Regional PV Manager ** Internal posting title: Deputy Country Safety Head, US and Canada **Location:** Bridgewater, NJ **Remote Work:** Hybrid **Job Type:** Full ... CSH at any time and may be exposed to GxP inspections standing in the first line (eg unannounced...limited to Medical, Regulatory, Quality, Commercial, Legal, and Country Manager . **Organization and Maintenance of Local PV Quality System**… more
- ICU Medical (San Diego, CA)
- …the general guidance of the Director, Quality Engineering, this Senior Manager , Quality Engineering-Device Software position manages the Quality activities related ... concerning all facets of process/product design, testing and release. The Quality Manager will be the San Diego ICU Medical function Management Representative in… more
