*This position may be based in New Haven, CT or Boston, MA and may require up to 10% travel
Position Summary
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.
Principal Responsibilities
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
Qualifications
- 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
Education
- 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
