(Poistunut julkaisusta)

Head of Quality and Regulatory Affairs
Desentum Oy

Alkuperäinen julkaisupäivä 16.9.2020

We are looking for an experienced quality/regulatory expert in Finland to manage and develop Desentum’s quality system and SOPs, as well as pharmaceutical/regulatory documentation of projects from discovery to clinical phase.

The main tasks are: 

  • Maintaining and developing Desentum’s quality system and SOPs
  • Ensuring that the documentation of drug development projects complies with the quality/regulatory requirements and supports marketing application
  • Following and interpreting pharmaceutical regulatory provisions
  • Auditing subcontactors and study centers

To succeed in this role, you need a good understanding of the overall drug development process and the related regulatory and quality requirements as well as experience in auditing. Additional experience in related topics (such as CMC) or knowledge of GDPR regulation is considered an advantage.

We offer a key role in the development of biomedical next-generation allergy treatments, a place in a highly motivated, agile and low-hierarchy team, and an independent job with an option to choose your location. Regular meetings in Espoo and occasional travelling is part of the work. The position offers an inside view and an opportunity to influence the direction of Desentum’s development programs. The job description can also be tailored according to your specific skills.

Responsibilities

  • Take a leading role in maintaining and developing Desentum’s quality system and documentation
  • Work closely with the R&D team, CMOs and CROs to ensure the quality, timing and regulatory value of documentation in different phases of drug development
  • Manage SOPs
  • Audit subcontractors and study centers
  • Other tasks possible according to your experience and interests

Qualifications

  • Suitable degree in a relevant field such as medicine, pharmacology or biotech
  • Minimum of 5 years of experience in the above-mentioned tasks in pharmaceutical industry
  • Good knowledge of the quality and regulatory aspects of pharmaceutical development and the overall drug development process
  • Complementary experience in other areas of pharmaceutical development (such as CMC/formulation/GDPR) can be an advantage
  • Good written and spoken communication skills in English and Finnish

To apply:

Please send your application letter and resume to info@desentum.fi