Corporate GCP/GVP Quality Assurance-R&D Center Sant Feliu de Llobregat

Fecha:  10-ago-2022
Ubicación:  SFEL - R&D SANT FELIU DE LLOBR

Mission

Coordination, maintenance and continuous improvement of the Almirall GCP & GVP Quality Management System ensuring compliance with applicable regulations and guidelines.  

Core activities will be focused on GCP nevertheless contribution in GVP will be essential (70/30).

Functions and responsibilities

  • To maintain the Quality System for GCP and GVP activities with the support of the clinical and pharmacovigilance teams.
  • To set up global risk-based audit programs: identification of audit candidates (personnel, facilities, documents, processes and systems) and risk mitigation strategies related to identified and potential compliance issues (specific audits and/or larger projects).
  • To lead, plan, conduct, document, follow-up and/or assist with audit activities (e.g. audits, mock inspections, training). GCP (phase I-IV): sponsor audits, clinical site audits, key deliverables (e.g. CSR, protocol, TMF); GVP: processes, business partners, vendors, affiliates; GXP computerized systems. Oversight of these activities when outsourced.
  • To identify and communicate quality and regulatory compliance issues to the applicable management through appropriate channels as well as recommending remediation.
  • To contribute in the technical guidance, leadership, mentoring and training being a key stakeholder in quality and compliance matters.
  • To lead (or support) the preparation and management of inspections by authorities as well as the audits performed by third parties to Almirall and attendance to those audits not taking place at Almirall premises (e.g. CRO, investigators sites, vendors), as applicable.
  • To participate in Clinical Study Teams and specific Project Teams.
  • CRO selection jointly with the clinical and pharmacovigilance departments.
  • To maintain current knowledge of regulations, standards and guidance documents.

 

Education

  • Bachelor's/Master's in Sciences, Biological Sciences or similar subject

Experience and requirements

  • +5 years experience in GCP and +2 in GVP
  • Strong knowledge of GCP, GVP, GxP regulations as well as computer systems validation and 21CFR Part 11 requirements
  • Experience dealing with Health Authority inspections and audits by external parties
  • Flexibility and willing to travel up to 15%
  • Fluency in English is essential – written and spoken
  • Detail oriented and analytical mindset with a clear focus on timelines and objectives