Senior Quality Supplier Manager - Biologics, AstraZeneca
AstraZeneca AB / Kemiingenjörsjobb / Södertälje
Observera att sista ansökningsdag har passerat.
Visa alla kemiingenjörsjobb i Södertälje,
Salem,
Ekerö,
Nykvarn,
Botkyrka eller i
hela Sverige Visa alla jobb hos AstraZeneca AB i Södertälje,
Stockholm,
Solna,
Göteborg,
Mölndal eller i
hela Sverige At AstraZeneca we turn ideas into life-changing medicines and strive to continuously meet the unmet needs of patients worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.
As the SQSM you will provide Quality oversite of Biologic CMO's globally. The successful candidate will have experience in Mammalian Cell Culture Production to include monoclonal antibody production, Microbial Fermentation, Drug Product filling, and Label and Packaging.
You will be a member of the Global Supplier Quality Organization. There are currently 4 SQSM's that support AZ's Biologic products. You will be the first SQSM to be based in Sweden. Your Bio colleagues are based at our Bio Hub in Gaithersburg, Maryland. We have a dynamic team that supports all our Bioproducts globally to help patients live better lives. Biologics is one of AZ's fastest areas of growth.
Main Duties and Responsibilities
You're responsible for the Quality management of assigned External Suppliers (contract manufacturer's and outside testing laboratories) and Quality management of assigned Supply Chains or third-party customers. In addition, you're responsible for all Quality activities that directly support execution of Quality Management of Suppliers for Biologics External Sourcing supply to customer. This includes, but is not limited to, the Quality System oversight and performance of activities such as change control, product quality complaints and deviation investigations. In addition you're responsible for product release, Quality Agreements between AZ and External Suppliers, between GSQ and AZ Operations Sites and between AZ and Third Parties.
The Senior Quality Supplier Manager is also responsible for supporting Quality Directors during issue management of quality issues impacting the ability to provide the right product at the right time to the customer and taking the lead for GSQ in IMTs. They serve as the primary interface between Quality and the Supply Chain Leads / 3rd Party Customers (as required); and as the Quality leader role in the critical issue of quality supply chain issues.
This position requires strong cross-functional ways of working with non-Quality members across the Supply Chain.
Key Accountabilities
* Develops and maintains effective business relationships with Suppliers
* Planning for, supporting and participating in Regulatory Agency inspections of their Suppliers and AZ sites (regarding Quality management for supply of external materials to the Sites)
* Responsible for Quality Supplier Management including but not limited to: Annual Assessments; Quality Agreements; trending and reporting of data; assessing, reviewing and improving quality systems at Suppliers; attendance at Quality and Business Review Meetings
* Maintains a high level of understanding of meaningful biologic production processes and quality systems.
* Performs the Quality review and/or approval of the following cGMP documentation for their Suppliers: Change Controls, Quality Investigations (Deviations, Product Quality Complaints), and Validation Plans, Protocols and Reports
* Responsible for quality issues escalation and resolution at the Suppliers, to ensure right product at the right time is delivered into the Product Supply Chain.
* Actively ensure GMP and regulatory compliance during the planning, execution and closeout phases of projects at their Supplier(s).
* As a member of a Supplier Management team, responsible for supporting cost-saving initiatives, value creation, performance standards, continuous improvements, and issue resolutions at their Supplier(s)
* Collaborates in data analysis and report creation on quality metrics and key performance indicators
Essential Requirements
* Bachelor degree in a science / technical field such as Pharmacy, Biology, Chemistry or Engineering. Validated broad experience in either the pharmaceutical operations environment or pharmaceutical Quality Assurance role
* Strong proven knowledge of Biologic processes, cGMPs, Quality Systems and the pharmaceutical supply chain environment. Also, a strong understanding of industry standards such as Pharmacopeia, ISO standards, etc.
* Proven experience working cross-functionally and leading significant improvement initiatives
* Ability to work independently under your own initiative.
* Ability to travel as required approximately 25% of their time.
Are you ready to bring new ideas and fresh thinking to the table? Great! We have one seat available and we hope it's yours.
For more information about the position please contact: Michael Kinley at
Welcome with your application no later than the 19th of January, 2020.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2019-12-20ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2019-12-27
Klicka på denna länk för att göra din ansökanFöretagAstrazeneca AB
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "R-065289".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Astrazeneca AB (org.nr 556011-7482)
Arbetsplats AstraZeneca
Jobbnummer 5014553
Observera att sista ansökningsdag har passerat.