Director, US Commercial & Distribution Quality Assurance

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 GxP’s 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 Alexion’s 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 performance-driven 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 Alexion’s expanding portfolio.
• Ensuring US Supply Chain areas are inspection-ready at all times and leading/supporting internal and external inspections/audits.
• Engaging with business leaders to ensure quality is built into long-term 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 future-focused.
• Mentoring other members of the Quality team.
  
  
  

Essential Skills/Experience

You will need to have:

• 8 years of hands-on Quality Assurance / Compliance and management experience in the pharmaceutical/biotech industry. Thorough knowledge of applicable local and global regulatory requirements required for GXP compliance.
• Bachelor’s degree in life science or any other related field required
• Extensive knowledge in a broad range of pharmaceutical regulatory activities and Quality Systems.
• Self-motivated, flexible, and creative leader, able to prioritize, multitask, and work in a fast-paced 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 office-based 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 problem-solving and non-linear 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.
• Hands-on 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 win-win 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 life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're 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 isn’t 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 under-served 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 patient's journeys. You’re supported by exceptional leaders ready to lift you in marketing, compliance, and beyond.

Ready to make an impact? Apply now!