Senior Specialist, Quality Distribution

at  Alexion PharmaceuticalsInc

POSITION SUMMARY

The Senior Specialist, Quality Distribution is a key member of the Quality Distribution Team who are responsible for the quality oversight of the distribution of Alexion products world-wide. The position ensures product shipments are managed in compliance with GDP requirements and applicable Alexion procedures.
The Senior Specialist, Quality Distribution works closely with the Alexion Global Supply Chain Team and is the primary Quality technical contact point with external distribution partners
(Distributors & Carriers).

QUALIFICATIONS

• Minimum of 5 years quality experience in a HPRA/FDA/EU &/or GMP/GDP regulated environment
• Thorough knowledge of temperature controlled product activities
• Thorough knowledge of cGMPs/GDPs and global regulatory requirements
• International exposure in positions interacting with and influencing site operations
• Sound awareness and understanding of pharmaceutical and biotech business, especially with regards to quality and regulatory requirements
• Strong Interpersonal skills and ability to interact constructively with all functions in a matrix organization environment
• Good verbal and written communication skills with well-structured communication and ability to present to various audience levels
• Previous experience leading inspection readiness and supporting multiple, global regulatory inspections.

EDUCATION

• Degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering)
  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.

• Responsible for Quality oversight of temperature controlled product activities in all markets in accordance with local and international requirements and Alexion planning schedules; insure products shipments are handled in accordance with GDP’s requirements
• Assess temperature controlled shipments and provides corresponding quality decision on product.
• Act as primary Quality technical contact point with distribution partners.
• Provide guidance, drive and monitor Quality issues related to temperature controlled products and GDP to resolution within the company and with external parties
• Review documentation including change controls, deviations, validation documentation, SOPs and specifications. Ensure documentation processes are followed to ensure appropriate management and notification to internal and external (E-room) collaborators.
• Ensure Quality Agreement with Alexion’s distribution contractors and carriers are established and maintained. Support the conduct of Quality and Operations review meeting with Distribution contractors
• Contribute to define and follow-up standard quality KPI and to review quality indicators with recommendation for actions for improvement in relation to GDP’s contractors
• Support the preparation of Health Authorities inspections and provide support for regulatory submissions