Poolia Life Science · Publicerad 27 nov

We are looking for a Quality Supplier Manager to join the Global Supplier Quality (GSQ) team at AstraZeneca in Södertälje for a 12-months consulting assignment. As a Quality Supplier Manager you will hold responsibility for the Quality management of assigned External Suppliers. Do you have broad experience in either the pharmaceutical operations environment or pharmaceutical Quality Assurance role, the ability to work independently under your own initiative and good problem-solving skills? Please don't hesitate and send in your application today. Welcome to Poolia Life Science!

About AstraZeneca and the Global Supplier Quality team

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. At AstraZeneca every one of our employees makes a difference to patient lives every day.
Big success can come from seeing potential in something small. We empower our people to seek these out, and we support them to pursue the opportunities they find.

We are now seeking for a Quality Supplier Manager to join the Global Supplier Quality (GSQ) team.

GSQ provides Quality oversight globally for approximately 1,600 supplier sites in AstraZeneca Operations and was launch in January 2018. The scope of the organization includes outsourced API, Biologics CMOs, Direct Materials, Formulation and Packing CMOs, Critical General Services, Contract Laboratories, Certification of Materials and the global IT System for Supplier Management.

The role

As a Quality Supplier Manager (QSM) you will hold responsibility for the Quality management of assigned External Suppliers.

You will be responsible for all Quality activities that directly support execution of Quality Management of Suppliers for assigned suppliers. This includes, but is not limited to, the Quality System oversight and/or performance of the following activities: change control, product quality complaint, S&L complaint and deviation investigations, quality issue management and escalation, Quality Agreements (establishment and maintenance) between AZ and External Suppliers and between GSQ and AZ Operations Sites.

Within the Global Supplier Quality (GSQ) organization you will hold responsibility for the oversight and ownership of Quality Systems. You will support the Quality Professionals involved in Quality Supplier and Product Supply Chain Management within the assigned categories.
In addition, the preparation and submission of periodic Supplier Quality Assessments, Regulatory Agency interactions and serving as Quality leaders on NPI, new supplier introductions, In Licensing, strategic sourcing projects, process optimization and product transfer projects, as these relate to Quality Supplier management, are also within the scope of this role. Regulatory Agency interaction includes preparation for, and management of, Regulatory Agency inspections at External Suppliers and AZ sites.

This position requires strong cross-functional ways of working with non-Quality members.
You should have the ability to travel nationally and internationally as this will be required for approximately 10% of your time.

Minimum Requirements - Education and Experience
  • Bachelor degree in a science / technical field such as Pharmacy, Biology, Chemistry or Engineering
  • Proven broad experience in either the pharmaceutical operations environment or pharmaceutical Quality Assurance role
  • Able to demonstrate strong knowledge of cGMPs, Quality Systems and the pharmaceutical supply chain environment
  • A strong understanding of industry standards such as Pharmacopeia, ISO standards, etc.
  • Experience of working cross-functionally and managing significant improvement initiatives - project management skills
Skills and Capabilities:
With the ability to work independently under your own initiative, you will be a strong influencer with good problem-solving skills.
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