Director US Commercial Distribution Quality Assurance
Director US Commercial Distribution Quality Assurance
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Salary Not Disclosed
1 Vacancy
Job Description
Introduction to role
Are you ready to lead and inspire a team dedicated to ensuring the highest standards of quality in the pharmaceutical industry As the Director of US Distribution Quality Assurance you will partner with our business teams to foster a Culture of Quality and build essential Quality skills within their teams. You will establish implement manage and execute a scalable Quality System for the US Supply Chain in compliance with the Alexion Quality Management System. Your role will be pivotal in maintaining Quality oversight of daily operations and ensuring compliance with GxPs and Quality Systems. This position requires a strong leader with extensive experience in Quality Assurance and the ability to function independently and within a matrix environment.
Accountabilities
You will be responsible for:
Providing Quality leadership to ensure compliance within the US Supply Chain functions to Alexions Global Quality and Compliance systems and associated procedures and standards.
Offering Quality expertise and leadership for Business Partners and their teams leading associated Quality activities.
Partnering with local regional and global operational groups to foster a proactive approach to quality and compliance.
Ensuring Alexion Policies Global Quality Standards Operating Procedures (SOPs) are implemented in accordance with US GDP GMP GXP and PV guidelines.
Maintaining a quality performancedriven operations model across the US Supply Chain teams focusing on risk management strategic program implementation operational performance effectiveness and efficient systems and processes.
Encouraging productive and collaborative relationships across functional areas and geographies including Supply Chain Operations and Central Quality.
Driving quality consistency and standardization across Supply Chain teams supporting operational excellence KPI creation and quality management oversight through monitoring of performance metrics.
Identifying communicating and mitigating quality and compliance performance risks in the US Supply Chain.
Leading the Quality Management Review (QMR) for the US Supply Chain.
Scaling and evolving business processes and systems to support Alexions expanding portfolio.
Ensuring US Supply Chain areas are inspectionready at all times and leading/supporting internal and external inspections/audits.
Engaging with business leaders to ensure quality is built into longterm planning.
Handling the review and implementation of Quality Improvement/remediation plans for partners.
Providing Quality support/partnership for US expansion and new product introductions.
Fostering an environment of talent development and learning to support a scalable and flexible organization that is futurefocused.
Mentoring other members of the Quality team.
Essential Skills/Experience
You will need to have:
8 years of handson Quality Assurance / Compliance and management experience in the pharmaceutical/biotech industry. Thorough knowledge of applicable local and global regulatory requirements required for GXP compliance.
Bachelors degree in life science or any other related field required
Extensive knowledge in a broad range of pharmaceutical regulatory activities and Quality Systems.
Selfmotivated flexible and creative leader able to prioritize multitask and work in a fastpaced and demanding environment
Proven track record of stakeholder management
Ability to motivate others around a shared goal and create a compelling vision and purpose for others to strive towards
Exceptional communication and interpersonal skills
Ability to work globally in a matrix environment
Ability to influence senior management peers and other colleagues without direct reporting lines
Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs
The duties of this role are generally conducted in an office environment. As is typical of an officebased role employees must be able with or without an accommodation to: use a computer; engage in communications via phone video and electronic messaging; engage in problemsolving and nonlinear thought analysis and dialogue; collaborate with others; maintain general availability during standard business hours.
Ability to freely travel within the US to our warehouse locations (up to 10
Desirable Skills/Experience
Advanced degree strongly preferred.
A track record in driving continuous improvement in a matrixed organization with multiple stakeholders.
Handson experience applying Project Management best practices and advanced planning and control methods to drive change in large organizations.
Strong Management & leadership ability
Highly developed facilitation and negotiation skills as well as the ability to resolve conflicts and develop winwin relationships with others within the business.
Advanced knowledge working with analytical tools (including PowerBI and Minitab)
Lean Green and/or Blackbelt Certification
When we put unexpected teams in the same room we unleash bold thinking with the power to inspire lifechanging medicines. Inperson working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
Joining Alexion means embracing an opportunity where work isnt ordinary. We are a beacon in the global Biopharmaceutical landscape. Our closeness to patients brings us closer to our work and each other. Combined with our brave pioneering spirit we are truly unique in R&D and healthcare. At Alexion grow and innovate in a business with a rapidly expanding portfolio. Enjoy the entrepreneurial spirit of a leading biotech while meeting the needs of some of the most underserved patients in the world. You will be empowered with tailored development programs designed not just for skill enhancement but for fostering a deep understanding of our patients journeys. Youre supported by exceptional leaders ready to lift you in marketing compliance and beyond.
Ready to make an impact Apply now!
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Date Posted
24Apr2025Closing Date
22May2025Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment training compensation promotion and other terms and conditions of employment based on race color religion creed or lack thereof sex sexual orientation age ancestry national origin ethnicity citizenship status marital status pregnancy (including childbirth breastfeeding or related medical conditions) parental status (including adoption or surrogacy) military status protected veteran status disability medical condition gender identity or expression genetic information mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation please contact Alexion participates in EVerify.Required Experience:
Director
Employment Type
Full-Time
