Dir, Head QA GCP/GVP

Dir, Head QA GCP/GVP

Sobi

Sweden or Switzerland

Role & Function

The Head QA GCP/GVP is responsible for:

  • Ensuring GCP/GVP quality & compliance oversight Providing strategic direction and leadership to R&D and Medical Affairs Departments under a Quality point of view
  • Developing the GCP/GVP audit strategy and annual audit program
  • Ensuring GCP and GVP inspection readiness (including Service providers)
  • The employee will in this role work with relevant stakeholders across the Sobi organization: R&D (Clin Dev/Drug Safety, RA), Medical Affairs, Commercial, Technical Operations and Global Quality.

Key Responsibilities

  • Ensure products, processes, systems and procedures within Sobi and its affiliates are in compliance with GCP/GVP regulations from a Quality perspective
  • Responsible for GCP/GVP/GCLP audit strategy and annual audit program
  • Responsible to provide strategic direction and leadership to R&D and Medical Affairs Departments under a Quality point of view
  • Responsible for Quality GCP/PV integration of new acquisition according to SOBI requirements
  • Responsible for GCP, GVP and GCLP inspection readiness (including Service providers) for leading GCP/GVP inspections/audits from authorities and clients
  • Ensure regular status report on performed GCP/GVP/GCLP audits, audit trending and agreed upon metrics to ensure oversight
  • Ensure budget adherence (Responsible for budget and budget follow-up for costs related to audits or other GCP/GVP/GCLP activities as applicable) and maintain resource overview and plans
  • Lead the GCP/GVP QA Team

Qualifications

  • University degree in Life Sciences or related discipline.
  • At least 10 years’ experience from the pharmaceutical industry with GCP and GVP responsibilities.
  • Experience of working with GCP/GVP audits/inspections
  • Excellent knowhow of the EU/US/RoW regulations within GCP /GVP
  • Excellent verbal and written communication skills

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© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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