Senior Quality System Manager

About Galderma

Galderma, the world's largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio to treat a range of dermatological conditions. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically defined and medically proven innovative solutions for the skin. For more information, please visit www.galderma.com.



Om Galderma

Galderma, världens största oberoende globala dermatologiska företag, grundades 1981 och finns i 100 länder med en omfattande produktportfölj för behandling av olika hudåkommor. Företaget samarbetar med vårdpersonal världen över för att tillgodose människors dermatologiska behov under livets olika faser. Galderma är ledande inom forskning och utveckling av vetenskapligt definierade och medicinskt dokumenterade lösningar för huden och dess åkommor. Mer information finns på www.galderma.com/se

Job description / ArbetsbeskrivningWe are now looking for a senior member to the Quality team in Uppsala. As Senior Quality System Manager at Galderma, you will be responsible for integrating and simplifying Galderma's current Quality System to meet regulatory requirements for Medical Device and Pharmaceuticals. You will also be the Quality department strategic representative for quality strategies for new production buildings and manufacturing processes.



Job responsibilities / Ditt uppdragIn this role, you will participate in the Quality Leadership team, ensuring long term planning is in place and strategic goals are met. In your day-to-day work you will be expected to:

* Prepare and present suggestions for Quality System improvements for the Quality Leadership team. Areas of specific interest are Risk Management, Validation philosophy including Validation Master Plan and Good Distribution Practices (GDP).
* Review and approve documents in the quality system
* Approve applicable CC
* Drive the development/simplification of processes and procedures
* Develop quality strategies for new production buildings and manufacturing processes
* Lead cross functional improvement projects



Minimum requirements/ Är du den vi söker?We are looking for an organized, driven and dedicated professional with substantial experience from working with validation, Quality Systems and/or Quality Assurance, medical device standards and pharmaceutical regulations, as well as regulations for product distribution. You also have experience and knowledge in how to comply to applicable GxP standards and how to develop systems that ensure establishment of objective evidence that the process/system consistently produces a result or product meeting its predetermined requirements. You have:

* A university degree within engineering or equivalent.
* Documented knowledge in ISO13485; 21CFR820 (QSR); GMP regulations.
* Knowledge in Pharma and aseptic regulations
* A high level of proficiency in English and preferably Swedish is required.
To thrive and be successful in this role you need to be motivated and driven to continuously improve the way we work, to support the vision for change and show the way for others. You also need to be flexible enough to quickly act according to new decisions and prioritizations.

Other important information/ Frågor och ansökanPlease apply with CV and cover letter via www.galderma.com no later than October 22nd. Selection and interviews might be done continuously so do not wait with your application.

If you want to know more about the role you are welcome to contact Talent Acquisition Manager Marlene Andersson at marlene.andersson@galderma.com