Location: New York, NY
Company: Argenx
& Implement the Comprehensive Training Program Manage GPS Procedural Document activities Management activities Actively participate in GPS Audit & Inspection Readiness, Support & Management Drive GPS Continuous Improvement (Issue Management, Process improvement, KPI development) The core duties and responsibilities of this role includes, but not limited to the following: Drive & Implement Comprehensive Training Program: Contribute to the Development of the Pharmacovigilance training program Maintain, expand, and deliver the pharmacovigilance training program (procedural documents, inspection readiness, refresher training, etc) Work closely with key stakeholders to support and/or implement pharmacovigilance
training across the organization Support the monitoring, maintaining, re-evaluating and updating the GPS training curricula backss training compliance to ensure GPS adheres to training timeline Support Training Doc Coordinator activities Manage GPS Procedural Document activities : Together with the GPS QM team members, manage GPS Procedural Document activities including contributing, developing, reviewing, and continually improving GPS process & procedures.
Proactively involved in cross functional Procedural Document activities/forums to determine relevance to GPS and assure appropriate GPS input and review are provided Monitor the status of and compliance with GPS Standard Operating
Procedures (SOPs) and other controlled documents.
Support document control through use of Veeva System Actively participate in GPS Audit & Inspection Readiness, Support & Management Actively involved in internal global GPS audit program and inspection readiness activities in collaboration with Gx P QA department Prepares GPS team members on inspection readiness activities Ensure appropriate documents are readily retrievable to use during an Inspection (GPS inspection slides, CVs, JDs, PVAs are contact information is updated and readily available) Support the coordination and preparation of GPS responses to audit &inspection findings. Drive GPS Continuous Improvement (Issue Management, Process improvement, KPI development) backss GPS issue management trends and implement actions plans to mitigate systemic causes Identify internal deviations and lead GPS team in determining corrective and preventive actions Guide the GPS team to determine root cause of issue to avoid recurrence In collaboration with QA, lead the implementation of corrective or preventive actions Contribute to development & subsequent evaluation of Key Performance Indicators, and adapt them to reflect the evolving business needs.
Liaise with the QA Department regarding GPS quality & compliance requirements/deliverables Represents GPS in cross-functional forums, committees, and initiatives Communicate and/or escalate issues to GPS management as appropriate SKILLS AND COMPETENCIES Excellent planning and organizational skills Excellent oral and written communication skills Ability to work in global environment Solution oriented with ability to prioritize and work independently Excellent presentation skills with the ability to communicate complex issues clearly Demonstrated ability to author and contribute to procedural documents Ability to motivate, influence, and collaborate with multidisciplinary teams Relevant computer skills, including proficiency with Microsoft Office Suite Fluency in written and spoken English.
EDUCATION, EXPERIENCE AND QUALIFICATIONS Bachelor's degree in shop, nursing, healthcare or other life-science or technical Field At least 3-5 years of experience in the medical/biotech industry with at least 3 years in pharmacovigilance/Drug Safety. Experience in Pharmacovigilance Quality Management activities is a plus Experience in GVP audit/inspection activities/process Excellent knowledge of drug development process, GXP quality and compliance requirements, pharmacovigilance regulatory requirements and GVP guidance documents At argenx we strive to create a welcoming and inclusive environment.
Here all applicants will receive equal consideration for employment without discrimination on the basis of race, color, religion, interaction, interactionual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer. If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at xyz X@.
Only inquiries related to an accommodation request will receive a response. PDN-9acb1e9d-05ce-4a4c-8a65-37177c013b5a
Quality Assurance (QA) jobs entail roles focused on ensuring that products or services meet established standards and customer expectations. People in QA positions are responsible for designing testing processes, creating test plans, identifying defects, and preventing defects by examining the production process. They aim to enhance product reliability and actively work to maintain quality consistency. QA roles often require keen attention to detail, strong problem-solving skills, and an understanding of both product specifications and customer needs. QA is an integral part of product development and maintenance, bridging the gap between the manufacturing processes and the end users to ensure a satisfactory experience.
Quality Assurance (QA) jobs involve ensuring that products, services, or software meet established standards of quality before they reach the consumer. Professionals in QA roles are responsible for identifying defects, implementing test strategies, and ensuring compliance with industry regulations. Key features of QA jobs include attention to detail, a systematic approach to problem-solving, and a focus on continuous improvement. QA specialists work to prevent errors and enhance customer satisfaction by aiming for zero defects and delivering reliable performance.
Quality Assurance (QA) jobs entail roles focused on ensuring that products or services meet established standards and customer expectations. People in QA positions are responsible for designing testing processes, creating test plans, identifying defects, and preventing defects by examining the production process. They aim to enhance product reliability and actively work to maintain quality consistency. QA roles often require keen attention to detail, strong problem-solving skills, and an understanding of both product specifications and customer needs. QA is an integral part of product development and maintenance, bridging the gap between the manufacturing processes and the end users to ensure a satisfactory experience.
Quality Assurance (QA) jobs involve ensuring that products or services meet specific standards and satisfy customer expectations. Professionals in this field focus on systematic processes and preventative measures during production or development to prevent mistakes and defects. QA roles typically require keen attention to detail, problem-solving skills, and knowledge of industry standards. They may encompass various tasks, such as developing quality assurance plans, conducting tests, and analyzing data to improve quality and reliability. QA jobs contribute significantly to a company's reputation by guaranteeing product consistency and safety.
