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Associate Director, US Distribution Quality Assurance

Location: Boston, United States Job reference: R-179851 Date posted: 09/13/2023

This is what you will do:

The Associate Director US Distribution Quality Assurance will be a strong leader who will partner with our business partners to develop a Culture of Quality within the business and build appropriate Quality skills within their teams. They will establish, implement, lead, and complete an appropriate and scalable Quality System for US Supply Chain in compliance with the Alexion Quality Management System and will be the primary Quality support/partner for the US Supply Chain organization.  They will maintain Quality oversight of the day to day operations of the US Supply Chain teams.  HeTheys encouraged to have strong experience in GxP’s and Quality Systems as well as the ability to function independently and in a matrix environment.  The candidate will have responsibility for managing direct and indirect staff.

You will be responsible for:

  • Providing Quality leadership to ensure roll out and ongoing compliance within the US Supply Chain functions to Alexion’s Global Quality and Compliance systems and associated procedures and standards.
  • Provide Quality expertise and leadership for their Business Partners and their team and lead associated Quality activities.
  • Partner with local, regional and global operational groups to foster a proactive approach to quality and compliance.
  • Ensure that Alexion Policies, Global Quality Standards Operating Procedures (SOPs) are implemented in accordance with US GDP, GMP, and other relevant GXP guidelines.
  • Responsible for maintaining a quality performance-driven operations model across the US Supply Chain teams, with focus on risk management, strategic program implementation, operational performance effectiveness and efficient systems and processes.
  • Cultivate productive and collaborative relationships, across functional areas and geographies, including (but not limited to) Commercial, Patient Safety, Medical, Supply Chain, Operations and Central Quality.
  • Drive quality consistency and standardization across Supply Chain teams, supporting operational excellence, KPI creation and quality strategic direction through monitoring of performance metrics.
  • Responsible to identify, communicate, and mitigate quality and compliance  performance risks in US Supply Chain.
  • Responsible for the Quality Management Review (QMR) for US Supply Chain.
  • Scale and evolve business processes and systems to support the needs of Alexion’s expanding portfolio.
  • Assure US Supply Chain areas under remit are in a state of inspection readiness at all time and leads/ supports internal and external inspections/audits. 
  • Partner with the business to foster a Culture of Quality within the business and build appropriate Quality skills within the team.
  • Ensure active cross functional stakeholder management to support Quality activities and stay up to date and informed of new or emerging GMP, GDP, and other relevant GxP changes.
  • Monitor GDP and other GXP compliance to regulations and Alexion’s procedures and communicate CAPAs and action plans to appropriate Quality Senior Learderip.
  • Lead and enable process and system improvement efforts to maximize efficiency on the Quality deliverables across US Supply Chain.
  • Engage with commercial business leaders to ensure quality is built into long term planning.
  • Manage the review and implementation of Quality Improvement/remediation plans for the partner.
  • Provide Quality support/partnership for US expansion and new product introductions.  This includes the maintenance and necessary updates to QAGs (Quality Agreements), initiation of audits, and support of required Quality documentation.
  • Foster an environment of talent development and learning to support a scalable and flexible organization that is future-focused.
  • Mentor other members of the Quality team.

You will need to have:

  • Strong Management & leadership ability.
  • Exceptional communication and interpersonal skills
  • 8+ years of hands-on Quality Assurance / Compliance and management experience in pharmaceutical/ biotech industry.Thorough knowledge of applicable local and global regulatory requirements required for GXP compliance.
  • 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.
  • Ability to motivate others around a shared goal and create a compelling vision and purpose for others to strive towards.
  • Proven track record of stakeholder management.
  • 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 up to 20%, (domestic and international)

We would prefer for you to have:

  • Bachelor’s degree in life science required. Advanced degree strongly preferred.
  • A track record in driving for continuous improvement in a matrixed organization with multiple stakeholders.
  • Hands-on experience applying Project Management best practice and advanced planning and control methods to drive change in large organizations.
  • 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 tool (including Powerbi and Minitab)
  • Lean Green and/or Blackbelt Certification

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.


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