Senior Manager, Development Quality Vendor Governance

32091
Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
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

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

You Will Need To Have

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

We Would Prefer For You To Have

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

Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.
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 [email protected]. Alexion participates in E-Verify.
AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you're interested in career opportunities with AstraZeneca, click here.