QA Manager (GVP/GCP)

TL;DR

QA Manager (GVP/GCP): Supporting the maintenance, oversight, development and continuous improvement of the GVP and GCP Quality Management System with an accent on compliance with regulations, auditing, and risk mitigation. Focus on developing quality plans, coordinating audits, preparing for inspections, and reviewing key documents.

Location: Onsite in Sant Feliu de Llobregat, Spain

Company

Pharmaceutical company building the future of medical dermatology by addressing unmet patient needs, recognized as a Top Employer in Spain since 2008 and in Germany since 2025.

What you will do

• Establish and maintain the Quality System for Clinical Trial and Pharmacovigilance activities, ensuring compliance with regulations and company policies.
• Develop GCP and GVP quality plans, audit plans, and risk mitigation strategies; coordinate and follow up on audits.
• Support preparation and management of inspections by authorities and third-party audits.
• Act as QA advisor in Clinical Study Teams and Project Teams; oversee outsourced QA activities.
• Review and approve procedures related to pharmacovigilance and clinical trials; draft QA procedures.
• Stay updated on regulations and collaborate on GxP training.

Requirements

• Proficiency in English
• Life-Science Degree
• Knowledge of Quality Normatives (GCP, GVP, relevant ICH, etc.)
• Courses in R&D Quality Assurance in pharmaceutical companies
• Knowledge of systems and computer networks; proficiency in computer programs
• Ability to draft scientific texts
• Two years of experience in QA for Clinical trials and/or Pharmacovigilance

Nice to have

• Understanding of GVP and GCP compliance and auditing processes
• Attention to detail and ability to verify documentation accuracy
• Analytical and problem-solving skills
• Ability to collaborate across teams and train staff
• Proficiency in quality management systems
• Commitment to safety and continuous improvement

Culture & Benefits

• Environment where people can grow and move forward
• Work with care, act with courage, keep things simple, focus innovation where it makes a difference
• Investment in people and independent thinking