14 Inspection Readiness Jobs

As a Quality Management System (QMS) Specialist, your role will involve establishing, implementing, and continuously improving the company's QMS to support its clinical-stage biopharmaceutical development programs while ensuring compliance with regulatory requirements such as FDA, EMA, ICH, and GxP standards like GMP, GDP, GCP, GLP. Your responsibilities will include: - **QMS Development & Implementation**: - Developing, implementing, and maintaining a phase-appropriate QMS aligned with regulatory requirements. - Establishing, reviewing, and updating Quality System documentation to support GxP operations. - Serving as the system owner for the electronic QMS and ensuring effective document co...

We are currently seeking a Senior TMF Specialist to join our diverse and dynamic team. As a Senior TMF Specialist at ICON, you will play a pivotal role in managing the Trial Master File (TMF) for clinical trials, ensuring compliance with regulatory requirements and contributing to the advancement of innovative treatments and therapies. What you will be doing: Perform a comprehensive eTMF completeness check/ periodic or milestone review and focus on cross checks, co-dependency checks and identify missing documents in Veeva Vault. Ensure eTMF is inspection ready for allocated studies. Conduct completeness check and update the expected document list (EDL) as on when required. Candidate would ha...

Role Overview: As a Regulatory (GxP) Compliance Engineer at Dassault Systmes, you will be a vital part of the Quality Compliance and Continual Improvement team within the global Research & Development organization. Your primary responsibility will be to ensure the global GxP compliance and readiness of the 3DEXPERIENCE platform on the cloud. Utilize your data analysis and business skills to assess compliance, drive continual improvement, and objectively demonstrate compliance. Key Responsibilities: - Analyze and understand the cloud compliance landscape including cloud customer expectations, industry expectations, regulatory enablement, competitive landscape, quality standards, certification...

Candidates with 15+ years exp. in end-to-end garment manufacturing ops Exp. in handling large-scale workforce & major international apparel clients Job Description Oversee end-to-end factory and business operations to meet cut-to-ship targets, ensuring audit-ready floors, strict safety compliance, and seamless cross-department coordination. Ensure every order meets customer specifications on quality, presentation, and documentation. Maintain inspection readiness 24 hours before schedule and drive a strong product quality culture to keep export rejects below 2%. Review orders and packing plans in advance, track WIP, and anticipate bottlenecks to sustain 95%+ line efficiency. Lead pre-producti...

As a Quality and Compliance Manager at CBRE, you will be responsible for supervising the team that supports quality assurance and quality control deliverables for small to medium-sized clients. You will play a crucial role in managing the delivery of contractual services to ensure all requirements are met efficiently. - Provide formal supervision to employees, monitor their training and development, conduct performance evaluations, and provide coaching - Coordinate and manage the team's daily activities, establish work schedules, assign tasks, and cross-train staff - Execute company and client compliance programs, participate in continuous improvement objectives, and report compliance status...

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description: OBJECTIVES/PURPOSE : Lead study operational strategy and planning and oversee execution of clinical studies for the assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan (CDP). In close collaboration with Clinical Operations Program Lead (COPL) and Clinical Study Manager (CSM) Responsible for ...

Role Overview: As a RTL/Sr. RTL, you will be responsible for managing the end-to-end project management of studies allocated to the RCO unit. This includes ensuring study deliveries within agreed timelines, budget, and quality standards. For outsourced studies, you will provide efficient Sponsor Oversight and be accountable for key deliverables and study success. Adherence to required procedures and quality standards in compliance with Sun Procedural Documents, ICH-GCP, and local regulations is expected from you. Key Responsibilities: - Plan and execute trials within agreed timelines, budget, and quality standards - Coordinate with the IRA team for planning and facilitating HA submission - C...

Role Overview: You will be the Controlled Documentation Lead in the R&D Quality department at Amgen, responsible for managing end-to-end lifecycle of controlled documents to ensure compliance with regulatory standards and internal quality procedures. Your role will involve coordinating document workflows, conducting QC reviews, maintaining document templates, and supporting audits and inspections. Key Responsibilities: - Coordinate and manage document workflows (e.g., SOPs, templates) to meet project timelines and compliance standards. - Track documentation milestones and follow up with contributors to ensure deadlines are met. - Provide technical editing and proofreading support to maintain...

Role Overview: As the Head of Clinical Operational Excellence at Novo Nordisk, you will be responsible for ensuring clinical quality, compliance, and operational excellence. Your role will involve performing risk assessments and trend analyses to address clinical quality risks proactively, ensuring audit and inspection readiness, representing the CDC in regional and global clinical quality forums, coordinating Quality Management Reviews (QMR), driving innovative solutions for operational efficiency, and implementing process improvements. You will play a key role in communicating with external Regulatory Authorities FDA, EMA, CDSCO, PMDO, and ensuring compliance with local regulatory requirem...

As the Global Safety Officer (GSO) for Marketed Products, your primary role is to ensure the safety and well-being of the assigned marketed products. 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. Key Responsibilities: - 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-...

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 land...

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...

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...

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 Eviden...