Job Description :
Job description:The Sr. Manager of Clinical Quality Assurance will be the core team member of clinical quality assurance department to perform day-to-day clinical quality operation and compliance activities to support success of the clinical studies sponsored or supported by Client. Essential Responsibilities:·                Lead and manage GCP audits, including clinical investigative site audits, clinical vendor audits, clinical department internal audits, TMF audits, and applicable study document audits, including CSRs. ·                Serve as a QA representative and support clinical study teams to provide compliance advice; participate in the review and approval of required clinical study documentsnbsp; ·                Implement study specific Clinical Quality Management Plans (CQMP) by using risk-based approach for Client clinical studies, and execute CQMP activities. ·                Lead or support continuous improvement of the Clinical Quality Management Systems (CQMS) and processes, including creation and revision of SOPs for GCP compliance. ·                Manage or support inspection readiness activities either per CQMP or led by the clinical teams. ·                Support clinical inspections conducted by regulatory agencies, including sponsor inspections, clinical investigative site inspections, and contract research organization (CRO) inspections. ·                Lead and/or support clinical non-compliance event investigations and CAPA implementation that may include monitoring non-compliance trends and effectiveness checks. ·                Track and provide clinical QA compliance metrics including study quality event trends·                Maintain a contemporary knowledge of current agency and industry trends, standards, and methodologies as related to GCPs·                Provide cross training development opportunities; mentor and coach junior QA team members upon request·                Travel required   Preferred Skills, Qualifications, or Technical Proficiencies:·                BA/BS degree in biological sciences, pharmacy or related field·                8+ years’ experience in clinical stage pharmaceutical companies with 5+ years’ experience in managing clinical study quality activities. Preferred Experience and Education:·                Ability to perform GCP Audits·                Experience in developing GCP processes for the best industry practices and training personnelThorough understanding of the quality systems that support GCP quality activities