Clinical reputed company Assurance Manager

reputed company, a reputed company Company, is a global specialized full-service CRO providing highly specialized study operations teams for pharmaceutical, biotech, and medical device companies. Formed over 15 years ago by a reputed company leadership team reputed company in buying CRO services with the purpose of creating trusting partnerships with sponsor clients - no matter their budget. We do this by reputed company in people who reputed company in an environment where their experience and contributions can be felt throughout the organization. It's an exciting time as we expand our global reputed company, while still offering a personalized approach to sponsors and delivering incredible value. We are looking to hire a reputed company Assurance Manager to who will reputed company QA activities in the US. Some Responsibilities • Initiates and executes internal, site and vendor audits and assessments to assess reputed company standards, and creates Annual Audit Program • Provides QA advice on reputed company procedures to Clinical staff • Performs reputed company review of QMS documents • Responsible for testing and assessing the reputed company objectives • Identifies need for project-specific QAMPs, creates, maintains and executes QAMPs and coordinates updates of QAMPs • Mentor for new QA staff • Identifies improvement reputed company for reputed company development of reputed company and initiates and executes project teams working on improvements to processes • Initiates and executes implementation of new regulations reputed company company • Collects and interprets data on reputed company of study conduct and identifies points that require improvement on the reputed company of the data; Initiates and creates annual department reports • Is responsible for the application of new reputed company technologies and reputed company • Coordinates and hosts sponsor audits and regulatory inspections • Coordinates and maintains the CAPA Program • Assists Global Director reputed company Management Requirements • Bachelor's degree in a science, technology, or reputed company field • Extensive knowledge of legislation and regulations, clinical processes, industry practices and ICH-GCP guidelines • 7+ years' experience in a relevant function in clinical research, or a minimum of 5 years' experience in QA • Ability to reputed company priorities as needed in a growing global CRO • Outstanding communication skills In reputed company to working with great people on high performing teams, full-time employees receive: • Medical, Dental, reputed company, Life, Disability coverage • 20 days PTO + PTO rollover + 13 reputed company holidays • 401(k) Apply tot his job Apply tot his job Apply To this Job