Sr Clinical Quality Systems Specialist

Biotechnology and Pharmaceutical Sr Clinical Quality Systems Specialist Job Description:Delivering on the promise of medical innovation begins at Boston Scientific By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. As we continue to transform the field of medical technology, we seek dedicated individuals who possess the integrity and creative spirit needed to thrive in an innovative company. Join a global organization that is fueled by the diversity and talent of its entire workforce. General Summary: Assists the Manager, Clinical Quality Systems, with internal quality operations of the assigned business area. Helps to implement and manage CQA quality systems, including Clinical CAPA management, clinical management review, clinical quality document management, clinical/CQA quality system training, and clinical inspection preparedness. Serves as CQA representative on quality teams as needed. Duties and Responsibilities: Responsible for the coordination and oversight of Clinical CAPA’s for Boston Scientific. Liaison with corporate, divisional and site personnel as required. Works directly with BSC functional clinical sites to ensure clinical CAPA requirements are understood and that the analyses and subsequent actions taken are conducted in a substantially compliant and defendable manner. Oversee maintenance of clinical corrective action files, which includes evaluation of actions for thoroughness and acceptability. Works cooperatively with other personnel to ensure closure of clinical CAPAs within required timeframes. Works with the Clinical Quality Systems Manager to plan, conduct and document the activities of the Clinical CAPA Review Board. Monitors clinical CAPA dates from initiation through closure. Prepares periodic reports to Clinical and CQA management on the status of the Clinical CAPA program. May develop and establish quality assurance policies, processes, procedures and controls ensuring the efficiency and ongoing improvement of the Clinical CAPA system. Assists in tracking training for Clinical Sciences staff, as needed, on Clinical Quality Systems and Clinical GSOPs and other documents. Maintains BSC’s Clinical Research Quality System Manual, Global Clinical Master SOP list, Clinical SOP Training Matrix, Clinical Glossary, CQA SOP List, Site Compliance Manual and CQA and Clinical training plans. Manages and facilitates the process for incorporating new and updated GSOPs, SOPs, WIs and forms into the clinical quality documentation system; obsoletes documents as appropriate and ensures all affected documents are updated (see bullet point above). Assists CQS Manager in organizing and coordinating the Clinical Quality Management Review process and appropriate CQS metrics. Maintains data on BSC internal and external regulatory inspections. Supports departmental, functional, divisional, and corporate quality goals and priorities. Helps to assure clinical quality systems are harmonized with corporate quality goals, requirements, and expectations. Keeps abreast of and helps to interpret current worldwide GCP regulatory requirements. Minimum Education and Experience: Life sciences degree Minimum 3 years’ experience in medical device or pharmaceutical industry in an area regulated by GCP and/or GMP regulations and guidelines. Must have experience in implementing and/or managing quality systems for regulated industries. Experience in clinical QA and/or compliance experience a plus. Clinical research experience as? monitor, CRA, or project manager a plus. Skills: Knowledge of Good Clinical Practices (FDA and ICH) and 21CFR Part 11 with respect to clinical processes and systems. Working knowledge of the drug/device development? process and clinical trial operations. Computer literate with experience with word processing, presentation, project management, and spreadsheet software. Characteristics: Highly professionalDiplomatic Highly organized and efficient? Detail orientedExcellent communication and interpersonal skills; well organized and focused communicator Analytical and decision-making skills; problem solving skills Demonstrated ability to manage multiple and complex projects.Presentation skills Ability to concentrate on the detail without losing sight of the overall picture. AbilityJob Experience:.Expected Travel Time: NoneThis company may offer relocation assistance. Please visit us online at www.bostonscientific.com for more information.