Associate Quality Director, AstraZeneca (temporary position)
AstraZeneca / Maskinförarjobb / Södertälje
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hela Sverige At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe.
Global Supplier Quality (GSQ) provides Quality oversight globally for approximately 1,600 supplier sites in AstraZeneca Operations. 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.
GSQ is now looking for an Associate Quality Director in EMEA to lead the Direct Materials Team for 12 months. You will be responsible for a team of approx. 10 Quality Supplier Managers located in the EMEA region.
The role includes the line management and Quality System performance of the following activities: change control, complaint and deviation investigations, quality issue management and escalation, QA Agreements, Supplier Quality Assessments and performance of Regulatory Agency interactions as needed. You will work closely with Quality Directors and GSQ Quality Professionals to support the performance of required Quality System activities for GSQ.
Main responsibilities:
* Line management of Quality Supplier Managers in the EMEA region.
* Ensure compliance with GMP and Regulatory requirements by providing proper coaching, mentoring and consultation to the team.
* Make decisions and advise the GSQ Team regarding quality and pharmaceutical technology issues within your area of expertise.
* Perform the Quality review and/or approval of cGMP documentation for your area
* Collaborate with and influence other Quality professionals across the organization to ensure consistent application and execution of key quality systems.
* 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.
* For QP (if applicable): Responsible for Batch record reviews and Batch release of products on the AZAB GES license.
Essential Requirements:
* Bachelor degree in a science / technical field.
* Proven broad experience in either the pharmaceutical operations environment or pharmaceutical Quality Assurance role. Strong demonstrated knowledge of cGMPs, Quality Systems and the pharmaceutical supply chain environment.
* Excellent oral and written communication skills in English.
* Demonstrated experience working cross-functionally and managing significant improvement initiatives.
To be successful in this role you need to have strong problem-solving skills and negotiating/influencing skills. An ability to work independently under your own initiative is also required. You need to be able to travel nationally and internationally approximately 25% of your time, of course planned ahead well in time.
Desirable Requirements:
* Evidence of line management
* Experience working in a PCO/PET organization or Lean/Six Sigma training
* Master's degree in quality assurance/Regulatory Affairs or other advanced scientific field
* Fulfill requirements to be a QP in Sweden: Degree complying with educational requirements as defined in LVFS 2004:7, §7. Proven experience in either pharmaceutical operations environment or pharmaceutical Quality Assurance role for at least 2 years.
Welcome with your application!
Please send in your application with your resume attached no later than June 9th. Interviews will be held continuously so don't hesitate, apply now!
For questions about the position please contact Malin Robin +46 8 552 510 54 or Cecilia Magnusson +46 8 553 255 17.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
Varaktighet, arbetstid
Heltid Temporary
Publiceringsdatum2019-05-17ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2019-06-07
Ange följande referens när du ansöker: R-051112
Klicka på denna länk för att göra din ansökanKontaktAstraZeneca
karin.serden@astrazeneca.comFöretagAstraZeneca
AdressAstraZeneca
15185
15185 0181
KontorsadressAstraallén
Jobbnummer 4793847
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