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Posted: Monday, March 13, 2017 10:19 AM

External Posting TitleSafety Quality and Compliance Oversight ManagerJob DescriptionThe Quality and Compliance Oversight Manager is responsible for managing the day to day activities of the late case investigation process and has direct oversight of the late case investigation team. Key responsibilities include working with investigators to complete and approve root cause investigations, escalating quality issues and performing CAPA activities, managing the quality and compliance metrics related to late case investigations across the Safety and Benefit Risk Management (SABR) organization, and establishing processes and tools to drive continuous quality improvement with in the SABR Quality team. The Quality and Compliance Oversight Manager may also be required to support audit activities, PV Regulatory Intelligence activities, and other areas within the SABR Quality organization to achieve department objectives.1. Perform the tracking and management of SABR late case investigation and compliance metrics as well as the development of quality dashboards / reports for dissemination to Senior Leadership and partners2. Oversee on-time Late Case investigations :a. Manage day to day activities of the QA late case investigation teamb. Mentor other departments in proper completion of Late Case Investigations, including proper root cause analysis techniques.c. Perform QC of investigations and corrective action activitiesd. Chair review meetings with investigators to ensure on time completion.e. Make process improvements as required3. Developing and implementing processes and tools to drive continuous quality improvement of data, processes or products across SABRLocationCambridge, MA, USJob CategoryDrug SafetyRequisition Number29302BRQualifications• Minimum of 5 years experience in the pharmaceutical / biopharmaceutical industry, medical, or life sciences highly desired• Knowledge of Post-Marketing and Clinical Trial Pharmacovigilance regulations• Direct experience in GCP compliant quality systems• Regulatory affairs, quality assurance or clinical departments experience is preferredEducationB.A. or B.S. degree or equivalent required, science degree preferredAbout BiogenBiogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies for the treatment of neurodegenerative and rare diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia.Founded in 1978, Biogen is one of the world’s oldest independent biotechnology companies. Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options. These include programs for Alzheimer’s Disease, amyotrophic lateral sclerosis (ALS), Parkinson’s disease, spinal muscular atrophy and neuropathic pain amongst others.With more than 7,000 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.Please be advised that all legitimate correspondence from a Biogen employee will come from "@biogen.com" email accounts..

Apply now at: https://cambridge-ma.geebo.com/jobs-online/view/directory/157/listing/239/id/533761823-safety-quality-and-compliance-/

• Location: Boston

• Post ID: 38701342 boston
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