Corporate Clinical Quality Assurance Officer

Who we are

At Ferrer we are a group of people who believe in the power of purpose. And our purpose is to make a positive impact in society and bring about change in an unjust world. We are the 24/7 activists fighting for a sustainable planet, equal opportunities for all and a healthy workplace. We reject greenwashing and empty promises - we are about action. That is why in 2022 we became a B Corp company.

Founded in Barcelona in 1959, our products are present in more than a hundred countries, and we have a team of over 1,800 people. Professionals that we empower to became leaders of change and to build meaningful careers.

Your mission 

• Ensuring Ferrer sponsored clinical development programs are conducted in accordance with international standards for Good Clinical Practice (GCP).
• Additional tasks include the maintenance and continuous improvement of the corporate Quality Management System for Clinical and Pharmacovigilance activities ensuring compliance with GCP, GVP and all relevant EU/FDA regulations and guidelines.

Responsibilities

• Work with project teams to identify, investigate and address non conformances arising from routine activities, audits and/or inspections in a risk-based manner.
• Collaborate with Clinical Development department to provide guidance and consultancy to resolve compliance issues. Ensure timely implementation and closure of CAPAs.
• Establish audit plans for GCP activities (i.e. vendors, investigator sites, TMF…) and internal processes related with the development of clinical studies, including identification of contracted resources as needed.
• Perform audits and/or supervise contract auditors in line with the audit plan and applicable procedures, including follow up upon closure and effectiveness verification.
• Manage and control vendor’s qualification process and due diligence
• Host regulatory inspections as needed, leading inspection readiness and preparation as well as post-inspection implementation and follow-up activities.
• Execute risk-based methodologies for the planning and execution of the quality management system strategy.
• Develop and review procedural documents describing clinical and PV processes ensuring compliance with relevant regulations. Maintenance of the document management system for clinical and PV activities.
• Ensure continuous improvement of the Clinical & PV Quality System by developing and monitoring global metrics and key indicators of critical processes
• Ensure initial and continuous GCP training.
• Provide guidance and input to stakeholders on quality and compliance issues using GCP/GVP knowledge and industry best practices.
• Participate in the development and implementation of the quality management system for non-clinical research studies conducted under GLP requirements.

Why Ferrer?

• Make a positive impact in society
• Participate in volunteering activities
• Grow in a culture of trust, responsibility, and constructive feedback
• Enjoy a flexible working model & collaborative office experience to enable innovation and teamworking
• Make a real difference to the team and to yourself
• Take advantage of opportunities for development & learning
• Discover a range of benefits to support your physical, emotional and financial wellbeing
• Customize your remuneration and benefit