Local Quality Manager, Boehringer Ingelheim, Sweden

Would you like to work as Local Quality Manager in a family-owned company with strong values? 

Boehringer Ingelheim is now looking for a responsible person (RP) for Sweden.

Do you want to play a key role in shaping the successful future of Boehringer Ingelheim Sweden? Here is a great opportunity to join on an interesting and inspiring journey during an ever changing and challenging environment with breakthrough therapies that improve the lives of many patients.

The main objective of the role is to have the overall responsibility for the Quality Management System (QMS) and Good Distribution Practice (GDP) activities for Boehringer Ingelheim Sweden. You will ensure that all processes and procedures are in compliance with pharmaceutical laws, the Boehringer Ingelheim Quality Manual and Policies as well as Industry Best Practices.

Major accountabilities

• Implement and maintain the local Quality Management System and Quality Manual in alignment with the global and regional Quality Manuals
• Perform regular Quality Management Reviews with the Local Leadership Team
• Ensure adequate processing of Technical Product Complaints and FMD Alerts. Establish an efficient recall organization.
• Management of Self-Inspections and ensure adequate regulatory inspection preparation.
• Ensure adequate escalation of issues and support their timely resolution & provide quality oversight for deviations and ensure that adequate corrective and preventive actions (CAPA’s) are implemented.
• Provide quality oversight for planned changes.
• Ensure adherence to GxP, any further legal and company internal regulations
• Ensure implementation of defined Key Performance Indicators in the area of responsibility to monitor on an on-going basis that relevant processes are in control and compliant. Ensure regular review and assessment of KPIs at the Leadership Team level.
• Ensure implementation of adequate training within the area of responsibility for all GxP activities by defining, planning and supporting training activities.
• Ensure that country specific requirements are communicated to the Regional and Global organizations for all GxP areas and assess their implications for the compliance of existing processes and systems. Initiate remediation activities, as necessary, to ensure ongoing compliance.

Qualifications

According to local health authority’s requirements, you preferably have a pharmaceutical degree or equivalent (HSLF-FS 2021:95). You have solid experience in the pharmaceutical industry, ideally in the Quality or related GMP/GDP areas. You set high goals for standards, performance for yourself and others.

You speak and write professional English and Swedish fluently.

Who are you?

As a person you are stable and trustworthy. You are a strong interactor who is authentic and mature. You make an impact and make your role visible. You are mindful of people and their well-being. You can see your role in a bigger perspective and like to cooperate with other functions and enjoy working with improvements.

Other information

This is an office-based position in Stockholm, Sweden, with the possibility to work hybrid. Preferably, you live in the Stockholm region. You will be part of a warm, friendly and cross-functional team.

You will also be in close contact with the regional MIDI office in Amsterdam, where you represent Sweden in an international constellation. A smaller proportion of travel is included in the role.

You will report directly to the General Manager and Head of Pharma, Sweden, with a dotted line reporting to the Head of Commercial Quality, MIDI region.

How to apply

If this sounds interesting, please apply through uploading your CV and a short cover letter (both in English) on the button above ("Sök denna tjänst"). If you want to learn more, please contact either of us:

Catharina Bergold or Torbjörn Ströberg
 

Welcome with your application!