Quality Lead

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.

If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

The Clinical Study Unit Quality Lead is the CSU expert responsible for the management of the Iberic Cluster clinical quality system, including (but not limited to) GCP compliance, quality processes, training and any other related quality aspects. As such, s/he is in charge of maintaining the appropriate qualification and continuous training of Cluster staff, as well as the corresponding documentation. S/he is a key CSU interlocutor and contributor for any quality document and GCP related topic. S/he is the key reference person for the resolution of any question related to clinical quality.

Key objectives:

- To develop, implement and maintain an integrated quality system to achieve compliance with GCPs and regulatory requirements, as well as operational excellence. This includes the countries of the Iberic cluster, i.e. Portugal and Spain.
- To lead continuous quality and performance improvement through processes optimization and innovation to positively impact productivity / quality / compliance and deliver to customers values derived from such innovations.
- To keep the integrated quality process efficient, adaptable and simple, for the user.
- Local Quality:

- Management of process improvement within the Cluster.
- Coordination of the local quality needs with Portugal and Spain
- Organisation and leadership of the development of local quality documents when required by CQ&CI or deemed relevant for the Iberic cluster.
- As an active member of the revision of quality documents, represents the Iberic cluster in the review of quality documents from other departments directly related to CSU activities.
- For Medical Affairs:

- Key provider of applicable quality documents and reference person to be consulted before any new study initiation.
- Maintain a historical file of the local quality documents.
- Permanent member of the Quality Board - MCO Iberia.
- GCP related quality topics:

- Key reference person, interlocutor and contributor for any GCP related quality topic occurring at Iberic cluster level:

- Definition of quality objectives: Key Performance Indicators related to quality.
- Management of quality risk within the Iberic cluster.
- Iberic cluster quality review:

- Give quality input into monitoring teams.
- Based on audit / inspection findings, to propose quality improvement and process optimization.
- Audit preparation, conduct and follow-up à CAPA implementation post audit / inspection.
- Investigations for serious GCP non-compliance / scientific misconduct.
- GCP inspection.
- Investigation and escalation of any relevant GCP / regulatory information.
- Involvement in audit performance of CROs working in collaboration with Medical Affairs.

**Requirements**:

- Background: ICH - GCP and Corporate SOPs. Degree in Health Sciences is preferable.
- Knowledge: ICH - GCP. Regulations on safety, clinical trials and clinical studies (local, European and American). Local and Corporate Quality Documents
- Language _(language and knowledge level_): English - Advanced.
- Professional experience: Two years experience in Clinical Quality.

Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.

We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.

But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment