Manager, US Quality Distribution & Commercial Quality

Alexion•New Haven, CT

3d•Hybrid

About The Position

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 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. This role supports QMS activities in the US by working together within US Quality Distribution. It closely assists US Commercial Quality to reach short- to mid-term goals and tasks related to Commercial and distribution operations in the US. The role will own relationships and activities associated with the day-to-day management of QMS functions aligned with the US Commercial Quality and Global Distribution Quality teams. The role provides support for other activities as needed. The candidate will embody the AstraZeneca, Alexion Rare Disease Unit values to “put Patients First,” “Follow the Science,” “Play to Win,” and “Do the Right Thing.” To be considered candidates must have strong experience in GxP, quality systems, and Pharmacovigilance. The ideal candidate will have the ability to function independently, assess risk, and evaluate competing priorities in a matrix environment. Successful candidates are flexible, able to operate amid ambiguity, have a natural curiosity to learn, and are eager to take ownership of the role.

Requirements

Bachelor's Degree in physical /life science or pharmacy, or other relevant degree with applicable industry experience.
3-5 years of hands-on Quality Assurance / Compliance and management experience in pharmaceutical/ biotech industry.
Knowledge in a broad range of pharmaceutical activities and Quality Systems.
Exceptional communication and interpersonal skills
Knowledge of industry business platforms including: Veeva Vault, SAP, MS Office systems and other custom programs; generally advanced computer skills
Knowledge of pharmacovigilance regulations and guidelines (FDA, EMA, PMDA, etc.)
Ability to work globally in a matrix environment with the demonstrable ability to adapt to a rapidly changing business environment that requires pragmatism and an ability to innovate for solutions
This is an individual contributor on-site/ hybrid role (minimum 3 days per week in office)
Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs
Ability to multi-task and prioritize work while operating autonomously with potential ambiguity
Strong leadership and organizational ability.
Ability to freely travel up to 15% (domestic and international)

Responsibilities

Works closely with US Distribution to manage the day-to-day deliverables associated with the US Quality Distribution program.
Execution of US Quality Distribution activities including distribution releases, in-house/ in-transit returns and stock transfer from 3PLs to forward stocking locations
Provided on-going support for Shipping & Logistics complaints, Supplier deviations, Temperature Excursions, CAPAs, and Change Controls.
Collaborate with Distribution and Global Supply Chain to ensure timely release of products to market; performs document review, data verification, and product disposition
Support the management of vendor quality oversight for US 3PLs, including KPI, deviation, CAPA, and change management.
Support the vendor quality oversight for US Commercial Distribution, including KPI, deviation, CAPA, and change management.
Drives workflow to ensure compliance.
Support the integration of business units across corporate structures.
Complete management in accordance with Quality Management Plan and procedures.
Support the coordination of Commercial Quality and Distribution Quality Management Review (QMR) including logistics, data collection and data analytics.
Support the management of Commercial Quality division level processes and procedures, in alignment with global quality QMS improvement projects, taking into account inputs such as Quality Systems KPI/metrics performance, findings in self-inspection program, findings from internal audit program.
Support the creation of department procedures and plans.
Manage workflows using various QMS tracking and Document Management software.
Represent US Quality Distribution and build positive relationships as an effective partner that provides value to and demonstrates the value of Quality to the business.
Focus on the management of authorized activities and the accuracy and quality of records
Ensure initial and continuous training programs are implemented and maintained
Ensure that root cause analysis is conducted for all audit findings and that CAPA are developed and implemented in a timely manner
Keep appropriate records of any delegated duties.
Support other initiatives as delegated.