Director QA and Qualified Person, Sweden Biologics
AstraZeneca / Biomedicinjobb / Södertälje
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Global Biologic Operations is establishing a new strategically important business unit in Sweden to support global supply of our existing biologic products and the impressive new product portfolio. The business environment is dynamic with a high pace of change. Your arena includes collaborating cross functionally in an international environment and organization. Ensuring our products are right first time every time for our patients is an imperative at AstraZeneca and will be key within your arena.
The role
We are recruiting a QA Director and Qualified Person to join Sweden Biologics Quality team, in Södertälje. The position is held within the Global Quality Organization and will report to the Site Quality Director. You will be accountable for implementing and lead the Quality Operations function, and become part of the site Quality Leadership team. You are to fulfil requirements, duties and responsibilities of a Qualified Person.
Main Duties and Responsibilities
* Implement and proactively lead the Quality Operations Function
* Ensure results, delivery against targets & KPI 's and continuously improve
* Ensure products as well as execution of business processes, standards and systems are in compliance with AstraZeneca procedures and competent authority requirements (LVFS, EMA, FDA, ICH etc)
* Ensure QA capabilities to proactively support the business and assure quality oversight
* Provide direction, development, and performance management to QA professionals within the function
* Act as Qualified Person. Responsible for release of products in compliance with regulatory requirements and AstraZeneca standards
* Ensure delegated QPs are trained to current standards
* Responsible for audits within own area, suggest responses and follow up on corporate and Health Authority Inspections
* Act as an escalation point for quality incidents and manage issues through to resolution together with AZ quality organisation
* Lead significant cross-functional projects, developing and implementing improved standards and ways of working
* Responsible for SHE and ensures Budget adherence
Essential Requirements
* Considerable experience, minimum 10 years, from pharmaceutical industry, including quality, manufacturing, development or regulatory
* Competent leader and people manager with several years' experience of leading teams
* Possesses a background in biologic or aseptic/sterile manufacturing
* Master's degree in Pharmacy, Chemistry, Engineering or relevant field
* Satisfying requirements for Qualified Person (LVFS 2004:7)
* Act as Qualified Person. Responsible for release of products in compliance with Marketing authorisation and AstraZeneca standards
* Strong knowledge and ability to apply GMP/GDP and major regulatory authority regulations
* Strong interpersonal skills and ability to collaborate and interact at multiple levels within a global organization, with business partners and competent authorities
* Possess excellent communication skills
* Fluent in Swedish and advanced in English
Desirable Requirements
* Several years' experience acting as a QP
* Business awareness and extensive experience across a range of areas
* Experience of using LEAN methods and ways of working
If you are interested, apply now!
We look forward to receiving your application.
If you have any questions or would like more information about the position, please contact Site Quality Director Malin Claesson, 08-55252641.
Welcome with your application no later than December 7, 2018
Interviews will be conducted during the application period.
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. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, our employees make a difference to patient lives every day. We're proud to have a unique workplace culture that inspires innovation and collaboration. Our values "We follow the science, We put patients first, We play to win, We do the right thing, We are entrepreneurial are key, every day, to all of us.
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 Permanent
Publiceringsdatum2018-11-13ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2018-11-20
Ange följande referens när du ansöker: R-039138
Klicka på denna länk för att göra din ansökanKontaktAstraZeneca
Helena.Kallin@astrazeneca.comFöretagAstraZeneca
AdressAstraZeneca
15185
15185 0181
KontorsadressAstraallén
Jobbnummer 4456018
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