GCP Manager – Swedish Orphan Biovitrum – Stockholm - Avslutad

The GCP Manager is responsible for the maintenance and training of Swedish Orphan Biovitrum GCP program, including development, regular update and training of the clinical Standard Operation Procedures (SOPs). Additionally, he or she is also responsible for planning and coordination to achieve inspection readiness for all clinical development studies.

We are now looking for you who have a University Degree in Life Science and qualified and several years experience from pharmaceutical industry work with GCP Management. You shall also have experience from cross-functional work creating alignment across multiple functional areas. You must have full understanding of the overall clinical study and filing process from an international HQ perspective.

Main assignments

  • Identify the requirement for new clinical SOPs and coordinate the development of such SOPs as well as coordinate the maintenance of existing clinical SOPs in accordance with applicable regulations, guidelines and SOPs
  • Write and implement SOPs in collaboration with relevant functions
  • Provide training of clinical SOPs
  • Lead the implementation and maintenance of the Company Learning Management System
  • Maintain knowledge of relevant non-clinical SOPs and participate in the internal review of such SOPs
  • Chair the SOP Review Team for the Development and Medical units
  • Plan and participate in external and internal GCP audits to ensure compliance with applicable regulations, guidelines, protocols and SOPs and write and review audit reports as well as provide recommendations for corrective and preventative actions for audits and inspections
  • Set up and maintain procedures to ensure a correct handling of non-compliance issues, compliance with study registration requirements as well as compliance with the Swedish Biobank regulation
  • Plan and lead the organization in preparing for inspections

Requirements:

  • University degree in Life Sciences
  • Several years experience from the pharmaceutical industry in the GCP responsibilities described above
    • Experience of working cross-functionally and creating alignment across multiple functional areas
    • Full understanding of the overall clinical study and filing process from an international HQ perspective
      • Experience from inspections from regulatory authorities (EU and US)
      • Experience from working with GCP related questions in a context where clinical activities are outsourced to a CRO

You are welcome to call Mr Knut Natt och Dag on 0722 166 800 or Mr Rolf Mayer on 0708 87 60 05 if you have any questions concerning this position. Send your application with your CV and a short personal letter to knut.nattochdag@aktivia.se as soon as possible due to our on-going work with recruitment projects. Write “GCP Manager” in the subject field.

You will be employed by Aktivia Science Work AB on a permanent position and will be placed and have all your reporting at Swedish Orphan Biovitrum. The employment is full time.

Aktivia Science Work AB is a consultancy and recruitment company within Life Science specialized in positions within the pharmaceutical industry. We have offices in Stockholm and in Lund and are part of Karolinska Institute Science Park in Stockholm and the Life Science centre in Lund. We are members in SwedenBIO and Medicon Valley Alliance. You can read more about us on our website, www.aktivia.se

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