Senior Manager - Supplier Quality (Materials)

This is what you will do:

This position operates within the Supplier Quality team to support the selection, qualification and post-qualification monitoring of GxP Suppliers with a focus on Material Qualification.  The Supplier Quality team operates globally across Alexion and sits within the wider Central Quality Systems and Compliance department. 

• Act as a SME for Alexion operations Material Qualification program.

• Develop and Manage a single Material Qualification process across Alexion operations.

• Support the management of the Global Supplier Quality program for Alexion operations.

• Manage all Supplier Quality inputs including quality agreements, material qualification packs, questionnaires, audits, change control, etc.

• Oversight of Material Review Board and other cross functional team meetings via matrix management.

• Support the Supplier Management Periodic Review process, including preparation of data for the review, summarizing the results and status to drive quality improvement opportunities within the supply chain.

• Develop and maintain positive relationships with internal and external stakeholders to ensure efficient performance.

You will be responsible for:

• Support the global Material Qualification processes and transition existing site-based processes to global processes.

• Lead a team for to administer the Material Qualification program.

• Mentor the Materials Qualification team.

• Identify process compliance gaps and develop/implement plans to resolve issues and mitigate quality risks, escalations to Leadership Team.

• Establish and track quality metrics for internal processes and identify and implement improvement opportunities.

• Support audits and inspections, as appropriate.

• Perform all responsibilities in accordance with company policies, procedures, federal regulations and safety requirements.

You will need to have:

• B.A. / B.Sc. or equivalent in Biological Sciences, Chemistry, Microbiology or other science.

• Minimum of 6+ years’ experience in Quality with medical device, pharmaceutical, or biologics experience.

• Experience in Supplier and Material Qualification required.

• Experience with Quality Risk Management and Structured Problem-Solving tools required

• A strong customer focus and ability to prioritize and adapt to business needs are required

We would prefer for you to have:

• Experience working with mature supplier quality system.

• Previous global Quality System development/deployment experience

• Experience supporting regulatory inspections

• Previous global Quality System development/deployment experience

• Experience managing Regulatory inspections

• Knowledge of applicable international GXP regulations and standards

• Strong leadership, negotiation, collaboration and influence skills in a matrix organization

• Demonstrated project management skills; experience leading cross-functional teams, and decision making

• Strong business partner with a focus on delivering results.

• Excellent communication skills

• Strong business partner with a focus on delivering results.

• Knowledge of applicable international GXP regulations and standards

• Strong ability to analyze systems, data

• Capable of identifying and mitigating risks

• Excellent written and verbal communication skills

• Experience with high performance teams, cross functional projects.

• Project management certification and/or experience is beneficial.

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.