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Posted: Wednesday, March 15, 2017 9:46 PM

External Posting TitleAssociate Director, Drug Safety - Quality Implementation and ExecutionJob DescriptionThe Associate Director, Quality Implementation and Execution provides direct supervision to the Quality Implementation and Execution Managers and Associates and is responsible for managing the Safety and Benefit Risk Management (SABR) global audit and inspection readiness program. Responsibilities will include working with Pharmacovigilance subject matter experts (SME) to evaluate systems for compliance, prepare SME for inspection and audit interviewing, and create storyboards. Additionally, this position is responsible for managing the SABR audit and CAPA process, tracking ad hoc regulatory requests and responses as well as the implementation of safety regulatory commitments as they pertain to Pharmacovigilance. This position may also be required to perform other activities within the SABR Quality organization to achieve department objectives.1. Provide direct supervision and management of Quality Implementation and Execution Associates (including mentoring).2. Manage the SABR global audit and inspection readiness program, including:a. Support and develop trainings for PV auditsb. Work with pharmacovigilance subject matter experts to review processes and evaluate for compliance to regulationsc. Prepare subject matter experts to present their functions during audits and aid in creating storyboards.d. Coordinate audit and inspection preparation activities and interface with regulators and R&D QC to facilitate inspection3. Support cross-functional global audit and inspections, including:a. Coordinate and provide support during mock auditsb. Coordinate SABR resources for audits requiring SABR supportc. Oversee and monitor any SABR-related audit findings and distribute to appropriate partiesd. Devise and implement action plan to address inspection findingse. Oversee and monitor progress of action planLocationCambridge, MA, USJob CategoryDrug SafetyRequisition Number29319BRQualifications• 7+ years’ experience in the pharmaceutical / biopharmaceutical industry, medical, or life sciences• Minimum of 3-4 years management and / or project management• 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 preferredEducationMaster’s level degree (or Bachelor’s Degree with relevant experience) in medical or life sciences or the equivalent experienceAbout 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 "" email accounts..

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