- Actalent (Edison, NJ)
- Actalent is hiring a GxP Auditor for a contract role. Preferred employees will possess prior Auditing experience (IS0 9001), and Vendor Audits. Description: Auditing ... scope. * Assists in the preparation and presentation of audit training materials. Supports the development and mentorship of...Takes an active role in projects as assigned by Manager . * Represents the department/project in providing solutions to… more
- AbbVie (North Chicago, IL)
- …day with an inclusive and collaborative business technology team. As a Senior IT Audit Project Manager in AbbVie Business Technology Solutions (BTS), you'll have ... deep, honest collaboration. In the role of IT Supplier Audit Project Manager , you will join a...third-party IT system and Services suppliers. Their execution in GXP compliance and quality assures that activities are performed… 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 At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, ... Manage and host client audits to ensure that client audit needs and expectations are met and that Aldevron...inspections (FDA, MHRA, EMA, etc). + Qualified as an Quality/ GXP Auditor by a third party.#LI-MR1 At Danaher we… 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
- J&J Family of Companies (New Brunswick, NJ)
- Senior Manager , Cybersecurity Quality and Data Integrity - 2406177026W **Description** Johnson & Johnson Services Inc., a member of the Johnson & Johnson Family of ... Companies, is recruiting for a **Senior Manager , Cybersecurity Quality and Data Integrity.** The primary and...technical areas of regulated product (Medical Device) Cybersecurity and GxP Data Integrity. This position will serve as the… 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
- 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
- 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
- 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
- Takeda Pharmaceuticals (Boston, MA)
- …best of my knowledge. **Job Description** **Job Title** : Validation Maintenance Manager **Location** : Lexington, MA **About the role:** As the Validation ... Maintenance Manager , you will provide leadership to the Validation Maintenance...to the Validation Maintenance Program for annual requalification of GxP manufacturing equipment used for commercial production, including developing… more
- Novo Nordisk (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 +… more
- ThermoFisher Scientific (Waltham, MA)
- …and evolving FDA safety requirements. + Lead and actively participate in audit and inspection readiness, support, and management together cross functional teams. + ... projects and programs is a plus) + Knowledge of the drug development process, GXP quality and compliance requirements, In some cases an equivalency, consisting of a… more