Senior Director Audit and Inspection
AstraZeneca / Apotekarjobb / Göteborg
2018-05-23
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hela Sverige At AstraZeneca we collaborate globally to make an impact and find answers to challenges. We do this with the upmost 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 the exceptional skills of our people from all over the globe.
In AstraZeneca, we want quality..
• ..to be a competitive advantage to deliver life-changing medicines
• ..to be an enabler to gain efficiencies
• ..to be owned by everyone
As the independent second line assurance function for Science Units, our mission in Quality Assurance is to achieve enduring excellence in auditing, quality management, quality risk assessment and enhance the Science Unit's quality mindset for the benefit of our patients.
We are now looking for a Senior Director, Audit and Inspection to lead our global team of competent auditors and to be part of our Global Quality Assurance Leadership Team.
Main duties and responsibilities
As the Senior Director, Audit & Inspection you will be leading our team of competent auditors in GCP, GVP and Good Regulatory Practice audits. As a member of Quality Assurance leadership team reporting to VP Quality Assurance, your are expected to influence the quality direction for the Science Units, although your main areas are strategic development and delivery of a GXP risk based robust quality assurance program as well as inspection management activities for Science Units. Key areas for accountability are:
* Accountable for maintaining an effective assurance program
* Lead strategic direction on assurance programs through engagement with stakeholder groups
* Provides effective compliance reporting to senior management across Science Units and supports strategic QA
* Leads Due Diligence activities
* Supports quality compliance investigations to support Issue Management Teams
* Accountable for effective process management for key quality processes (i.e. audit, inspection management)
* Responsible for sponsor and submission-related regulatory inspection support strategy, oversight and response and interacts with relevant regulatory authorities
* Accountable for reporting of quality and quality related risks and compliance gaps to Audit Committee and senior management and across the SU organization
Essential skills
* Audit expertise is required for this role as is
* Extensive experience from Inspection facilitation
* Senior professional - compliance, Masters degree or equivalent in science related area.
* Significant experience in pharmaceuticals or a related industry
* Knowledge and experience of corporate governance, GXP regulations, laws and standards
* Demonstrable leadership skills and experience
Location: Gothenburg, Sweden, Cambridge, UK or Gaithersburg US.
If you are interested - Apply today!
For more information about the position please contact Johan Widestrand at +46705885963 or
Welcome with your application no later than June 6, 2018
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.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2018-05-23ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2018-06-06
Ange följande referens när du ansöker: R-028571
Klicka på denna länk för att göra din ansökanKontaktAstraZeneca
asa.lothigius@astrazeneca.comFöretagAstraZeneca
AdressAstraZeneca
43183
43183 1480
KontorsadressPepparedsleden 1
Jobbnummer 4161221
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