Meet the TEAM

Meet the Team: Tibisay Estupiñan
Quality and Compliance Manager.

Tibisay Estupiñan
Tibisay Estupiñan
Quality and Compliance Manager

Tibisay specializes in continuous process improvement, QMS implementation, documentation management, deviations, root cause analysis and change management processes in compliance with both GMP and GVP.

She is an expert in GxP system validation and customized training development and has led QMS development, implementation and remediation.

Tibisay has also managed third party audit programs, coordinated programs of client audits and is certified in the management of quality systems according to both ISO 9001 and ISO 22000.

Tell us about a day in the life of a Q&C Manager.

Since the Quality Management System (QMS) is supporting all the services provided by Arriello, The Quality & Compliance Manager must have a full oversight of the projects and the potential challenges within the processes in the company. Revision of QMS, Managing nonconformities and of course attending audits are one of the main activities executed day by day. As Compliance Officer (an integral part of the Q&C role) questions related with data protection, anti-bribery/anti-corruption, or business compliance are also part of the responsibilities.

What do you like best about collaborating with clients / the work you do day-to-day?

What I like the most is being able to help the clients to fulfil the regulatory requirements with excellence. In my role, I’ve had the opportunity to lead cross-functional teams in implementing cutting-edge quality management systems and processes that not only ensure compliance with current regulations but also anticipate future requirements. Arriello fosters a culture of collaboration and empowerment, where every team member is encouraged to contribute their expertise and insights to drive continuous improvement.

What is a current trend you are seeing in the industry and how does it impact our clients and patients?

One current trend in the pharmaceutical consultancy industry is the increasing demand for strategic consulting services related to market access and health economics. All this is done with a simplification approach, but still requirements and expectations. This is when risks assessments and automation make a significant impact on clients processes; By leveraging consultancy expertise in these areas, clients can enhance their ability to develop, commercialize, and deliver innovative therapies that positively impact patient care and outcomes.

What is unique about working for Arriello – tell us about your career journey?

What truly stands out about working at Arriello is the collaborative and dynamic environment. My career journey as a Quality and Compliance Manager at Arriello has been marked by continuous learning and growth. Overall, my career journey as a Quality and Compliance Manager at Arriello has been both challenging and rewarding. I’m proud to be part of a company that is not only shaping the future of regulatory compliance, but also empowering its employees to thrive and excel in their roles.

What truly sets Arriello apart is its people-centric approach, where in challenging situations, the employees know they can count that Arriello, as an organization, will support