4 Inspection Readiness Jobs

As a Regulatory (GxP) Compliance Engineer at Dassault Systmes, you will play a crucial role in ensuring the global GxP compliance and readiness of the 3DEXPERIENCE platform on the cloud. Your primary responsibility will be to use your data analysis and business skills to assess compliance and the effectiveness of management systems while driving continual improvement. You will be part of the Quality Compliance and Continual Improvement team within the global Research & Development organization. Your key responsibilities will include analyzing and understanding the cloud compliance landscape, including cloud customer expectations, industry expectations, regulatory enablement, competitive landscape, quality standards, certifications, frameworks, as well as information security and privacy standards and frameworks. You will need to have a strong understanding of GxP regulations such as GMP, GCP, and GLP, and guidelines from regulatory bodies like FDA, EMA, and ICH. Additionally, you should possess risk management expertise to identify, assess, and mitigate compliance risks related to systems, processes, and data. Your role will also involve utilizing your documentation and validation skills to create, manage, and review detailed documentation, including validation protocols, reports, SOPs, and audit trails. You will need to be skilled in conducting internal audits, preparing for external regulatory inspections, managing CAPAs, and addressing compliance gaps effectively. Strong communication skills will be essential to coordinate with cross-functional teams, provide training on GxP principles, and communicate compliance expectations to stakeholders. You will also be required to liaise with customers, understand their compliance needs, and ensure alignment with GxP standards. Your qualifications should include a Bachelor's or Master's degree, along with 3-5 years of relevant experience in the area of Life Science & Health Care. Proficiency in software development lifecycle methodologies, quality management practices, software testing and quality assurance best practices, program and project management methodologies, and industry regulations and compliance expectations for software providers is required. Experience with risk assessment methodologies, program and project management, continuous improvement, risk management, change management, and customer relationship management will be beneficial. Moreover, you should have excellent English language communication skills, both verbal and written, and be proficient in Microsoft Office Professional. Familiarity with information security management best practices and controls, including ISO 27001, ISO 27701, SOC 2, is desired. At Dassault Systmes, we are committed to building inclusive and diverse teams globally, where all employees feel empowered to bring their whole selves to work. We believe in fostering opportunities for all individuals to participate in a harmonized Workforce of the Future.,

The PV Scientist Manager is responsible for contributing to the planning, preparation, writing, and review of non-medical portions of aggregate reports. Collaborating with affiliates and other internal Amgen partners, the PV Scientist Manager ensures timely deliverables. Additionally, reviewing Adverse Events/Serious Adverse Events from clinical trials is part of the role. Under the guidance of the Global PV Sr. Scientist or Lead, the PV Scientist Manager reviews study protocols, statistical analysis plans, and other clinical study-related documents. They provide input on the design of safety data tables, figures, and listings from clinical studies. Participation in the development of safety-related data collection forms, attending study team meetings, and conducting signal detection, evaluation, and management are key responsibilities. The PV Scientist Manager performs data analysis to evaluate safety signals, collaborates with the Global Safety Organization (GSO) on analysis results, and prepares safety assessment reports and other safety documents. They search and review adverse event data and relevant literature for signal detection purposes, participate in Safety Governance processes, and prepare presentations on safety recommendations for decision-making bodies. Assisting in the development of risk management strategies, providing content for risk management plans, updating regional risk management plans, overseeing risk minimization activities, and preparing responses to regulatory inquiries related to risk management plans are critical tasks. Supporting activities related to new drug applications and regulatory filings, contributing to safety-related regulatory strategies, and assisting in developing safety-related regulatory activities are also part of the role. In terms of Inspection Readiness, the PV Scientist Manager undertakes activities as delegated by the QPPV, maintains a state of inspection readiness, and acts as a representative and point of contact for Health Authority Inspections and Internal Process Audits within their role and responsibilities. Contributing to the Global Patient Safety (GPS) team, the PV Scientist Manager assists in developing, improving, and standardizing pharmacovigilance processes and methods. They also participate in teams for implementing new processes and methods within the Therapeutic Area. Basic Qualifications and Experience: - Masters or Bachelor's degree in a relevant field - Minimum of 9+ years of experience The PV Scientist Manager's role encompasses a wide range of responsibilities in pharmacovigilance, risk management, regulatory activities, and inspection readiness, contributing significantly to the safety and effectiveness of pharmaceutical products.,

Are you passionate about driving clinical quality and compliance Do you have a proven track record in clinical operations and a knack for innovation and process improvement If you're ready to take on a leadership role that makes a real impact, we invite you to explore this exciting opportunity, apply today for a life-changing career! As the Head of Clinical Operational Excellence, you will play a pivotal role in ensuring clinical quality, compliance, and operational excellence. Your key responsibilities will include performing risk assessments and trend analyses to proactively address clinical quality risks, ensuring audit and inspection readiness including CAPA documentation and stakeholder communication, representing the CDC in regional and global clinical quality forums, ensuring compliance with local regulatory requirements, coordinating Quality Management Reviews (QMR), developing and executing yearly training plans aligned with operational strategies, driving innovative solutions for operational efficiency such as digital visit tracking and RBQM, identifying and implementing process improvements, conducting stakeholder satisfaction checks, measuring the effectiveness of new processes, and communicating with external Regulatory Authorities FDA, EMA, CDSCO, PMDO. To be successful in this role, you should have 15+ years of experience in clinical operations with a minimum of 3 years in clinical quality, 5 years of direct team handling experience with 360* performance management, completed qualifications in Medical, Pharmacy, Life Sciences, or another related field, a track record of driving innovation and process improvements in clinical operations, experience with digital tools and systems for operational excellence, excellent communication, and stakeholder management skills. The Clinical Development Centre (CDC) India is at the forefront of ensuring clinical quality and operational excellence. Based in a fast-paced and dynamic environment, the department proactively addresses clinical quality risks through risk assessments and trend analyses, ensures audit and inspection readiness, maintains compliance with local regulatory requirements, drives innovative solutions such as digital visit tracking and RBQM, represents CDC in global forums, and fosters collaboration with external regulatory authorities. With a culture of continuous improvement and a commitment to operational efficiency, the team thrives on delivering impactful results that make a difference. If you are interested in submitting your application, please upload your CV and motivational letter online. Internal candidates are kindly requested to inform their line Managers before applying. The deadline for applications is 01st Aug. 2025. Novo Nordisk is committed to an inclusive recruitment process and equality of opportunity for all job applicants. The company recognizes the importance of creating an inclusive culture that celebrates the diversity of employees, patients served, and communities operated in. Together, Novo Nordisk strives to be life changing.,

The Global Safety Officer (GSO) for Marketed Products plays a crucial role in ensuring the safety and well-being of the assigned marketed products. As a GSO, you will be responsible for establishing the strategy, direction, and priorities of pharmacovigilance activities related to the assigned products. Your accountability extends to overseeing the overall safety profile, making product-related decisions, and delivering on all associated responsibilities. Leading the Safety Analysis Team (SAT), Global Safety Team (GST), and serving as a core member of the Executive Safety Committee (ESC), you will be an integral part of the safety governance structure. Additionally, as a member of the Evidence Generation Team, you will contribute to the evidence generation process. When necessary, you may act as a delegate for the TAH and manage Global Safety Scientists. Your key activities will involve various tasks depending on the assigned product(s). These activities include but are not limited to: - Developing and maintaining core reference safety information - Conducting benefit-risk evaluations - Participating in the product label process - Developing strategies for clinical trial safety - Leading responses to safety-related inquiries from regulatory agencies - Performing signal detection activities - Evaluating safety signals and determining further analysis strategies - Developing risk management plans - Ensuring timely preparation of periodic safety reports - Participating in safety governance meetings - Representing Global Patient Safety in commercialization processes - Undertaking activities for inspection readiness - Participating in safety agreement development and review process - Interacting with external stakeholders on safety-related topics - Providing safety input to support legal needs - Overseeing day-to-day activities of the Global Safety Physician (if applicable) - Providing training, coaching, mentoring, and development of staff - Assisting in the recruitment of talented personnel - Disseminating and representing corporate and departmental information to staff The ideal candidate for this position should hold a Medical Degree (MBBS or MD) from an accredited medical school and have a minimum of 8 years of relevant experience in product safety within the bio/pharmaceutical industry, CRO, or regulatory agency. Previous management and/or mentoring experience, as well as clinical/medical research experience, are preferred qualifications.,