Job Description

This is what you will do:

As part of the Development Quality Team, you will drive Quality Culture with Development, Regulatory and Safety stakeholders, through learning, embedding a quality mindset, and executing on continuous improvement opportunities. Support key process/system improvements in collaboration with Development, Regulatory and Safety functions, Development Quality peers, and other Quality colleagues.

You will be responsible for:

• Assist with quality vendor oversight and oversight of overall Development, Regulatory and Safety vendor management in collaboration with cross functional partners
• Ensure GxP qualification assessments are carried out as per process
• Partner with Development, Regulatory and Safety Alliance Directors and Global Strategic Sourcing on Vendor Governance
• Partner with R&D Audit group related to vendor qualification, and routine audits to ensure a robust vendor audit program is carried out
• Support Quality Agreement negotiation and execution as per process
• Ensure compliance with vendor quality oversight based on Quality Agreements with strategic partners
• Supports the development, monitoring, and reporting of KQIs with vendors
• Collaborate with cross functional partners with regard to strategic partner vendor oversight
• Support the Development Quality team in vendor quality issue assessments
• Support audit and inspection notifications to strategic partners
• Working cross functionally on eliminating redundancies, improving knowledge management to increase productivity, transparency, and quality

You will need to have:

• Bachelor\xe2\x80\x99s or Higher Degree in life sciences or similar scientific subject
• 4+ years of experience in the R&D quality assurance area, with experience in vendor oversight and management
• Understanding of GCP quality management systems, issue and risk assessments, quality measures and metrics
• High attention to detail and accuracy
• Quality management experience
• Excellent communication skills; fluent oral and written English
• 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.

We would prefer for you to have:

• Good analytical, problem-solving and negotiation skills
• Experience in working in a global role
• Cultural Awareness and Positive attitude in managing change

#LI-Hybrid

Date Posted 18-Jul-2023

Closing Date 17-Sep-2023

Alexion 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 E-Verify.

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