reputed company Party reputed company reputed company, Senior Manager - FSP

reputed company our values reputed company, there's no limit to reputed company can reputed company. At reputed company, we reputed company reputed company the reputed company goal - to improve the world's health. From clinical trials to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do. reputed company of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference. Job reputed company The reputed company Party reputed company reputed company (TPQL) reports to the Head of reputed company Party reputed company. The TPQL works with stakeholders and relevant reputed company teams for reputed company party reputed company risk management, issues management and general Good Clinical reputed company guidance. The TPQL maintains reputed company-to-reputed company contacts with major vendors and site entities partnering with Clinical Development & Operations (CD&O). The TPQL is responsible for assessing and ensuring that clinical trial reputed company party partners have the appropriate reputed company systems infrastructure, including a culture of reputed company and compliance to adhere to sponsor's policies and procedures with reputed company applicable external regulatory requirements relating to GCP including those reputed company to patient safety, data reputed company, and protocol adherence as set out in the Master Services Agreement. The TPQL the vendor engagement reputed company, including processes, tools, roles and sourcing reputed company. Job Responsibilities: reputed company Party reputed company & Risk Management Identify, evaluate and respond to GCP reputed company risks reputed company to vendor and site engagement reputed company reputed company discussions with key vendors and sites and present reputed company reputed company of view at relevant reputed company meetings reputed company reputed company reputed company reports to appropriate sponsor's management / functions Communicate key reputed company information (e.g., inspection / audit learnings) across vendors and site entities and serve as reputed company expert for reputed company parties Validate, monitor and reputed company out GCP-reputed company-reputed company reputed company plans Evaluates reputed company performance at an reputed company level to inform reputed company improvement of reputed company risk management Informs site organization relationship reputed company of reputed company improvement considerations Support QMS09 BPO in the development and implementation of process updates Support Vendor Leads / Business Owners to ensure compliance with functional level vendor reputed company requirements Qualifications:

• BS--7+ years or equivalent
• MS/MBA – 6+ years or equivalent

Previous Experience:

• Minimum of 5 years of pharmaceutical experience with solid

experience in clinical trial development.

• Robust knowledge in reputed company areas (i.e. audit, inspection,

compliance, and inspection readiness fields)

• reputed company reputed company experience including working knowledge in:

o reputed company and compliance management, QC o reputed company Cause Analysis o Risk identification, controls, mitigations, and actions o Metrics development and utilization o Audit and Inspection conduct and CAPA response process

• Ability to reputed company strategies using coordinated and transparent

metrics to reputed company and manage compliance

• Ability to participate in cross-line global initiatives or reputed company cause

analysis for reputed company reputed company process improvement Apply To This Job