Job Description

Location: Mississauga, Canada; Boston, United States; New Haven, United States Job reference: R-172370 Date posted: 02/01/2024

This is what you will do:

As part of the Development Quality Process team, you will drive Quality culture with Development, Regulatory, and Safety stakeholders and key business partners, through learning, embedding a quality approach, and completing continuous improvement opportunities. This role will 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 supplier oversight and partnership-level management in collaboration with Alliance Directors and Global Strategic Sourcing on supplier governance
• Partner with AZ Clinical Audit and Supplier QA groups to support supplier qualification and routine audits (as required).
• Develop, negotiate, and execute Quality Agreements; assess and report compliance of Strategic and non-Strategic GxP suppliers
• Support audit and inspection notifications to GxP suppliers
• Support the development, monitoring, and reporting of KQIs with GxP suppliers
• Collaborate with cross-functional partners with regards to GxP supplier oversight
• Support the Development Quality team as point of escalation to support the resolution of supplier quality issues
• Work cross-functionally on eliminating redundancies and improving knowledge management of supplier governance

You will need to have:

• Bachelor\'s or Higher Degree in life sciences or similar scientific subject
• 5 years of proven experience in the R&D quality assurance area, with increasing level of experience and responsibility in supplier oversight and management
• Practical knowledge and application of global GCP regulations (i.e., FDA, EMA, MHRA, Health Canada, etc.), ICH guidelines and industry standards
• Understanding of GCP quality management systems, issue and risk assessments, quality measures and metrics
• Hands-on experience with the use of QMS systems (document management, deviations, CAPAs).
• Skilled in developing collaborative internal and external relationships
• High-level of accountability; a driver with an exceptional ability to manage multiple tasks in a fast-paced, cross functional, and matrixed environment with changing priorities
• High attention to detail and accuracy
• Quality management experience (supplier quality SME, audit/inspection experience)
• Excellent communication (oral and written) and presentation skills
• Fluent oral and written English
• Experience in process improvement and project management
• 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.

Expectation of working in the office 3 days a week statement: When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need 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.

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 demeanor in managing change

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.

Alexion Pharmaceuticals