Alexion Pharmaceuticals Associate Director, Risk Management in Boston, Massachusetts
*This position can be based from the Alexion location of Boston, MA or can be remote/virtual, based anywhere in the United States and may require up to 20% travel.
The Associate Director of Risk Management will play an exciting and key role in deploying Alexion’s Next Generation Active Risk Management program, across the Global Quality Organization. In this new role, she/he will lead, support, and provide expert direction on quality risk management related projects, risk facilitations, trainings, and workshops. In this global role, the new team member will work closely with business partners across the various GxP disciplines.
Risk Management & Culture
Responsible for development, execution, and facilitation of: Risk Assessments (GxP), Risk Management Workshops, and Risk Management Training
Partner with business units to ensure consistency in risk management and integration of risk-based thinking
Assist with the identification of potential systemic gaps and develop and propose remediation plans for global and / or cross-functional implementation
Serve as an active member and contributor to support health authority inspections, response preparation and remediation on QRM related topics.
Build a partnership model across the business to utilize data and insights to look at innovative ways to assess and inform on risk, outcome, and control (e.g. internal auditing, QMS Compliance)
Risk Strategy & Program
Responsible for assisting in the evaluation of the effectiveness and ongoing evolution of Alexion’s Quality Risk Management Program and Approaches through development of mitigation and improvement plans.
Direct the implementation of compliant risk management operations within area of responsibility by guiding teams on accurate and timely responses to risk management issues and ensure strategic approach to meeting company objectives.
Conduct analysis of risk assessments and rankings and develop risk analytics and reporting dashboards to support Management Reviews and inform decision making.
Drive innovation of risk management processes by identifying opportunities for continuous improvement.
Support the updating and maintenance of Alexion's Global Quality Risk Register Platform
Broad knowledge and experience in risk management tools and approaches
Experience and knowledge in one or more of the GXP areas
Strong problem-solving skills
Ability to multi-task projects and evaluate priorities with minimal supervision
Must have a well–developed ability to constructively work across functional areas and levels to achieve results.
Proficiency in developing presentations to facilitate meaningful discussions, with clearly communicated analysis, findings, and impact
Passion for excellence
Bachelor’s degree in business management, engineering, or scientific discipline
6+ years of experience leading and supporting risk management activities in a pharmaceutical, biotech, medical device, or related regulated industry
Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. As a leader in rare diseases for more than 25 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D) as well as the first and only approved Factor Xa inhibitor reversal agent. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, metabolic disorders and cardiology. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.