LEO Pharma

Pharmacovigilance (PV) and Affiliate Auditor – Senior Professional

Global Quality Audits

LEO Pharma has embarked on a very ambitious journey to become the world’s preferred dermatology care partner – and that is why we need you.
You now have a unique chance to be part of Global Quality for LEO Pharma.
Join the new Audit Hub based in Segrate and be part of an audit corps with highly skilled auditors currently based in Denmark but working globally.

In the Global Quality you will get the opportunity to make a significant difference for people with serious skin diseases all over the world. You will have a strong influence on the quality at our +30 affiliates where PV, GDP/GMP/RA activities are performed as well as our external partners with whom we have PV agreement with. Your contribution will ensure an applicable compliance level is maintained.

The job

As Senior Quality Auditor, you will contribute to the audit risk assessment oversight and perform audits of our Affiliates, PV service providers and Distributor’s with PV agreement. You will represent the Quality Assurance department in medium to high complex projects ensuring Global Audit strategy and potential be engage within due diligence activities, if needed.

You will impact quality within existing and successful products as well as our exciting product
pipeline where biologics are of growing importance. You master the ability to have eye for the details and at the same time see the big picture. Your analytical skills and structured approach ensure a solid audit agenda and audit conduct. Your communication skills ensure that the audit is perceived by stakeholders as a learning session and that the audit report can be clearly understood by people that did not attend the audit. The Veeva Vault system is used to control the audit process.

You will travel world-wide approx. 50 – 60 days a year.
Further some of your key responsibilities:

  • Act as Lead Auditor with the authority to assess and influence directly on quality level of the affiliates, PV system and within the PV/RA/GMP/GDP through audit conduct, improving known procedures and development of new principles/high-level procedures.
  • Subject matter expert within PV area with focus on how relevant regulations impact the quality level of the PV system of LEO.
  • Represent the audit function in a leading role during Authority Inspections world-wide
  • Evaluation of quality questionnaires
  • Creation of training material and perform training/knowledge within Global QA.

Your qualifications

  • Master’s degree in scientific subjects
  • Minimum 5 years of experience within a PV regulated area with significant expertise within two or more of the following fields: PV key processes, Affiliates (GMP/GDP/RA/PV), Suppliers/distributors with PV responsibilities and PV service providers
  • Lead auditor skills within Pharmacovigilance
  • Profound knowledge within pharmaceutical production or the pharmaceutical industry
  • Fluency in English is a must. Knowledge of other languages (ex. Italian) is a plus.

It is expected that you will live up to LEO values: Integrity, Customer focus, Innovation, Passion and Adaptability.

Further the Seniority demand have a complex decision making, proactivity and global perspective, strategic mindset, have good influence towards your stakeholders and building collaborative relationships.

Join our mission to help more people achieve healthy skin

Hundreds of millions of people around the globe are suffering from an untreated skin disease. Helping these people to get a better life is what LEO Pharma is all about. By understanding their needs and wishes we will improve existing treatments and break new land to uncover the solutions of tomorrow.
By joining LEO Pharma, you will get the opportunity to create results, develop yourself among highly skilled colleagues while taking on our quest to become the preferred dermatology care partner improving people’s lives around the world and at the same time create profitable growth.

Contact and application

Please apply via the link at our website and remember to attach application and CV in English. 

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Segrate, Milano (IT)

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