- Novo Nordisk Inc. (Plainsboro, NJ)
- …safety, data integrity and regulatory compliance are sufficient Monitor and escalate GxP compliance signals and issues to GxP Support management Physical ... Health Canada), and escalating quality concerns. Relationships This position reports to the Associate Director of GXP Oversight and/or Head of GXP Support.… 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 ... proactive and strategic way and through collaboration with other GxP Quality representatives, act as QA point person for...to ensure appropriate management review of all quality and compliance related topics including the review of Key Quality… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to case processing activities. Relationships Reports to the Executive Director , NAO Patient Safety with cross-functional working relationships within Medical, ... objectives. Essential Functions ADMINISTRATION: Serves as a delegate for Executive Director for collaboration with Document Management team and Regulatory Affairs to… more
- Catalent (Philadelphia, PA)
- Position: Director QualityLocation: Philadelphia, PAPosition Summary: The Quality function is to build, monitor, and sustain a robust and effective quality system ... and Australian agencies and other international and/or local health authorities.The Director of Quality is responsible for providing leadership and Quality… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … compliance with SDEA requirements. Relationships This position reports to the Director , Case Review & Compliance Reporting within Patient Safety. This ... to the following: all units in Patient Safety, NNI GXP Support, NNI Legal, NNI Compliance , NNI Commercial, NNI Finance, Global Business Services (GBS), PV… more
- Merck & Co. (Rahway, NJ)
- …and regulations (ie, OSHA, RCRA, Air, Soil, Water Pollution Control and GXP ) to ensure operational compliance within applicable permit guidelines.Contributing to ... Position Description: Powerhouse Chief Engineer Under the direction of the Associate Director of Engineering, The Chief Engineer is responsible for the supervision… more
- FUJIFILM Holdings America Corporation (College Station, TX)
- …Engineer, under general direction, will be responsible for oversight of all GxP -Regulated Computerized Systems at all applicable points of the computerized system ... lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data Integrity requirements. This… more
- AbbVie (North Chicago, IL)
- …This is an experienced level compliance position that reports to the Associate Director GxP Compliance . This individual is expected to identify and ... Independently plan and conduct internal system audits and external GxP supplier audits + Maintain approved supplier list, global...compliance issues + Provide guidance and training on GxP regulations and guidelines to GxP auditors… more
- Bristol Myers Squibb (Summit, NJ)
- …Learning. + Lead a team of centralized LMS administrators to drive efficiency and compliance across the GxP Learning landscape. + Define and optimize competency ... + Translating the Enterprise Learning Team's vision and strategy into execution of GxP learning initiatives and applying core competencies across the GxP … more
- AbbVie (North Chicago, IL)
- …system for role-based training globally. + Acquire and maintain in-depth knowledge of GXP compliance trends in order to develop strategies for the delivery ... for monitoring the effectiveness of the learning management system and maintaining compliance with policies, procedures, and applicable GXP regulations. Key… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Sr Director , Global IT Quality Compliance Date: Mar 28, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 54945 ... accordance with Teva policy, standards and procedures. The Senior Director IT Quality Compliance leads the organization...organization to ensure computerized systems used in support of GxP processes are effective and managed in compliance… more
- CSL Behring (King Of Prussia, PA)
- **The Opportunity** The Senior Director I&T Risk and Compliance Management Services for CSL's technology function (I&T), develops and implements a comprehensive ... risk management, quality and compliance program, tailored to the global I&T function, that...mitigation strategies, managing a team of professionals responsible for GxP activities, testing excellence, evaluation and ongoing management of… more
- Amicus Therapeutics (Marlow, OK)
- …+ Serve as a key contact for regulatory agencies, managing interactions and responses. + Global GxP Compliance : + Ensure compliance of global GxP Quality ... Senior Director , Head of Global Quality Systems Location Marlow,...Oversee the quality of all computer systems used in GxP environments, ensuring compliance with relevant standards… 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 ... proactive and strategic way and through collaboration with other GxP Quality representatives, act as QA point person for...to ensure appropriate management review of all quality and compliance related topics including the review of Key Quality… more
- Catalent Pharma Solutions (Bloomington, IN)
- …quality systems and documentation, as well as other process improvement initiatives, in compliance with GxP regulations + Possess a strong background in ... **Position Summary** The Director of Quality Systems is responsible for managing...regulatory compliance , expertise in quality management systems and document control… more
- J&J Family of Companies (Titusville, NJ)
- Associate Director , Temperature Strategy & Execution - 2406177829W **Description** Johnson & Johnson Innovative Medicine Research & Development (JJIM R&D), part of ... the Johnson & Johnson Family of Companies, is recruiting for an Associate Director , Temperature Strategy & Execution within Clinical Supply Chain (CSC). The position… more
- Frontier Medicines (Boston, MA)
- …on improving product quality. + Implementing process improvements required to ensure GxP compliance in early clinical development environment with strategic view ... Join us as the Senior Manager/Associate Director of Quality Assurance at Frontier, where precision...departmental and company standard operating procedures (SOPs) from a GxP perspective. + Ensure supplier quality objectives are met.… more
- Sumitomo Pharma (Morrisville, NC)
- **Sr. Director , Cell Quality** Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need ... seeking a dynamic, highly motivated, and experienced individual for the position of Sr. Director , Cell Quality. The Sr. Director , Cell Quality is the Site… more
- AbbVie (Worcester, MA)
- …Job Description AbbVie Bioresearch Center (ABC) is hiring an Associate Director Automation & Manufacturing Systems position to lead the Operational Technology ... while working in a proactive and motivating team environment. The Associate Director Automation & Manufacturing position will afford you the opportunity to lead… more
- Catalent Pharma Solutions (Philadelphia, PA)
- **Position: Director Quality** **Location: Philadelphia, PA** **Position Summary:** The Quality function is to build, monitor, and sustain a robust and effective ... Australian agencies and other international and/or local health authorities. The Director of Quality is responsible for providing leadership and Quality Management… more
