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NORDIC QA/RA MANAGER

  • Externa annonser
  • Remote Solna
  • 2024-10-27

Hemsida Servier Sverige AB

Fullständig jobbeskrivning

About the job

Servier – the global pharmaceutical group with particular focus and expertise in the fields of oncology, cardiometabolism & venous disease, neuroscience & immuno-inflammation – is now looking for a Quality Assurance Manager also working with Regulatory Affairs for the Nordic markets. The position is situated in nice facilities at the Swedish affiliate in Frösundavik, Solna.

If you are looking for a role that is broad as well as challenging and which gives you the possibility to influence the development of the QA and RA functions in the Nordics, then this could be the position for you!

The Servier Group

Servier is a global pharmaceutical group governed by a non-profit foundation, with its headquarters in France (Suresnes). With a strong international presence in over 150 countries and a revenue of 5.3 billion euros in 2022/2023, Servier employs 21,900 people worldwide. Entirely independent, the Servier group invest over 20% of brand-name revenue in research and development and reinvest all profit to grow Servier’s business and drive progress by developing new treatments for patients. For more information, please visit www.servier.com/en

Tasks and Responsibilities

Servier Nordics is a small organization which provides the opportunity to work with very varied tasks, both routine and more demanding projects, and to have broad responsibilities. There is currently around 16 products in the Nordics.

In this role you will be the responsible for Quality Assurance (Pharmaceutical Responsibility) within the Servier affiliates in the Nordics and you will manage or co-ordinate all related activities and support both the Nordics and HQ with your expertise in this area. In this role you will also be managing Regulatory tasks and should be able to work independently. For the right person there could also be the possibility to take on the RP responsibility.

You work in close collaboration with the Local Regulatory Affairs Manager Nordics and the roles will support and act as back up for each other.

Your tasks will include:

Quality Assurance (Pharmaceutical Responsibility):

· Managing and co-ordinating the maintenance of the Nordic Quality Management System, including writing/updating SOPs.

· Updating systems and databases.

· Preparedness for and management of potential recalls and falsified medicines.

· Managing complaints, including reconciliation and reporting to authorities.

· Co-ordination and management of deviations, CAPAs, change controls.

· Co-ordination and management of partners and agreements.

· Overall responsibility and co-ordination of self-inspections, audits, inspections and related CAPAs.

· Ensuring the wholesaler’s licence in Denmark. Possibly assuming the RP responsibility.

· Providing expertise in Quality Assurance matters.

· Performing internal training

· Collaborating internally with global functions as well as Nordic team and externally with service providers in the Nordics as well as contacts with the Nordic authorities.

Regulatory Affairs:

· Activities related to the maintenance of existing MAs, new MAs and launch as well as withdrawals.

· Providing local information or documents required for submissions and eCTD review when applicable.

· Co-ordinating local translations of Product Information.

· Managing local submissions.

· Post-approval activities.

· Managing artwork.

· Managing shortage notifications and exemptions.

· Managing local Risk Minimization Measures and DHPC.

· Updating regulatory systems and databases.

· Regulatory Intelligence.

· Providing expertise in Regulatory Affairs matters.

· Collaborating internally with global functions as well as Nordic team and externally with service providers in the Nordics as well as contacts with the Nordic authorities.

Suitable candidate

Qualifications

  • University degree in Life Sciences.
  • 5+ years’ experience in Quality Assurance and Regulatory Affairs at Affiliate level in the Nordics.
  • Broad experience and knowledge of GDP as well as Regulatory legislation and procedures within EU as well in the Nordic countries.
  • Highly proficient in spoken and written Swedish as well as English
  • Verbal and writing skills in other Nordic languages is a plus.

Personal attributes

To be successful in this position you should enjoy taking responsibility, take initiative and be able to work independently, but at the same time flexible and good at teamwork. You get things done, are able to prioritize and prepared to take on responsibility for both routine tasks and more demanding projects. You are structured and thorough, but at the same time pragmatic, and good at communication. Supporting others and sharing your expertise within the team to move forward together is something that you enjoy.

Why Servier?

At Servier you will be working in an international environment where the company atmosphere is caring and considerate. You will join a small team of motivated people who are experts in what they do and with a positive spirit in the office. We encourage all our people to develop their skills and allow them to be the best version of themselves by providing training, entrusting them with responsibilities and offering them opportunities to move jobs or locations, all within a caring and considerate environment.

Are you interested in this position?

If you are ready to take on the challenge as Nordic Quality Assurance Manager at Servier, you can apply here.

The interview process for the position is on-going, so get in touch or apply at your earliest convenience but at the very latest by 21st July 2024. Desired start of the position is in September – October 2024, depending on availability.

The QA Manager reports to the Local Regulatory Affairs Manager Nordics, Ulrika Mörtberg. The position could be a part time (minimum 75%) or full time contract as agreed.

The local company policy provides the possibility to work from home some days per week.

For more information, contact Ulrika Mörtberg at 072 450 0112 or via [email protected].

Due to GDPR we do not handle your personal information through e-mail.

Job Types: Full-time, Part-time

Pay: From 1,00kr per month

Expected hours: 30 – 40 per week

Work Location: Hybrid remote in Solna

Application Deadline: 21-07-2024

  • Externa annonser
  • Remote Solna
  • 2024-10-27

Hemsida Servier Sverige AB

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