Alexion Pharmaceuticals Associate Director, Quality Risk Analysis 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 Quality Risk Analysis will be instrumental in contributing to the growth, integration, and further advancement of Quality Risk Management and Risk Analysis across Alexion’s Global Quality and Operations organizations. She/He will be responsible for the oversight and maintenance of the Quality Risk Register and Risk Reporting platform and serve as the key point of contact for the organization for this core service. She/He will actively be involved in risk workshops and risk assessments, as well as the launch of a new Center of Excellence in Risk Management. This is a new and exciting role for the organization and will shape the strategy for risk reporting and risk management plan, which will include establishing key risk indicators, thresholds and organizational risk appetite framework.
Procedures & Processes
Responsible for assiting 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.
Work in close collaboration with the other business units to ensure consistency in risk assessment, management, mitigation, risk register documentation and actioning.
Culture & Innovation
Support the development, execution and/or facilitation of Risk Assessments (GxP), Risk Workshops, and Risk Management Training.
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.
Drive a performance management culture by mobilizing and developing individuals at all levels, encouraging cross-team collaboration to achieve positive results for the organization.
Risk Analysis & Reporting
Maintain Alexion’s Global Quality Risk Register Platform, including reporting and development of analytics, and key attributes of enterprise risks.
Monitor, analyze and prepare reporting of risks within the Quality Operation’s business units, including establishing risk thresholds and key risk indicators.
Conduct analysis of risk assessments and rankings and develop risk analytics and reporting dashboards to support Management Reviews and inform decision making.
Contribute insights and key takeaways to Quarterly Management Reviews, Executive Management Reviews and Board presentations.
Support development of the data strategy for risk management, as part of a larger data and analytics roadmap for Quality.
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)
Challenge and stress test current risks and controls, self-assessments and strategies.
Coordinate with other organizational Risk and Compliance teams as appropriate to ensure integrated end to end coverage of risks and coordination of monitoring, assessment and other activities.
Contribute to the team’s efficient and effective operation by close collaboration with and monitoring risk management projects and activities to control costs, mitigate risks, adhere to business and industry standards and implement industry best practices.
Broad knowledge and experience in risk management tools and techniques (including, but not limited to: FMEA, FMECA, FTA, PRA)
Strong knowledge of GXP compliance, as well as USP, PIC/S, ICH and FDA guidelines is required
Strong working knowledge of Operational Risk program elements and principles including but not limited to Internal & External Operational Losses, Risk Control Self Assessments (RCSA), Key Risk Indicators, and Scenario Analysis
Strong analytical and problem-solving skills
Experienced in use of statistical software (e.g., SAS, Excel VBA, Minitab and Tableau); solid and demonstrated understanding of advanced statistical approaches
Knowledge of Quality Systems
Expertise in project management principles and application including the ability to manage multiple projects simultaneously; Ability to multi-task projects and evaluate priorities with minimal supervision
Communication and Collaboration
Must possess strong verbal and communication skills, and a well–developed ability to constructively work across functional areas and levels to achieve results.
Ability to work in a Global Environment
Proficiency in developing presentations to facilitate meaningful discussions, with clearly communicated analysis, findings, and impact
Must demonstrate the ability to grow and perform in areas of broader responsibility
Passion for excellence
Bachelor’s degree in business management, engineering or science discipline is required
Direct experience leading and supporting risk management activities in a pharmaceutical, medical device, or related regulated industry, is required (risk facilitation, training, etc.)
8+ years broad experience in Pharmaceutical Industry or a related regulated industry. Valid operational experience includes quality management, risk management or other relevant experience working at a regulatory health authority. Broad business awareness a plus.
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.