Yaribey Rodriguez works within Quotient Sciences’ Quality Assurance team in Miami, Fl. She discusses her career with the company and what she enjoys most about her role.
What I like most about working at Quotient Sciences is to know that I am making a difference in the field of medical care. To know that I took part in the development of future treatments that can save lives, and that it was done with the outermost passion, dedication, and with the best team.
– Yaribey Rodriguez
What does a Senior Director GCP QA do at Quotient Sciences?
A Senior Director GCP QA is responsible for implementing, maintaining, and continuously improving Good Clinical Practice (GCP) compliance programs and the Quality Management Systems (QMS) to support the clinical trial activities at Quotient Sciences Miami. This role provides QA oversight to assure clinical trial activities are conducted in compliance with applicable regulations, ICH GCP guidelines, and internal policies and procedures. Other tasks include managing and conducting internal and supplier audits, hosting client audits, and serving as the point of contact and host for all regulatory inspections.
Describe a typical day in the Quality Assurance Department.
The Quality Department always has exciting and interesting days. Typically, it includes both required meetings and also daily firefighting activities to ensure the site is complaint and audit ready. These are accompanied by constant multitasking and rapidly shifting priorities to ensure the business continues to run smoothly. You would never be bored!
How has your career progressed since joining us?
I joined Quotient Sciences under the tile of Director, GCP QA for the Miami site. Since then, I have developed to be a Senior Director, GCP QA.
What experience did you have before you worked at Quotient Sciences?
Before Quotient Sciences, I was an Operational Excellence Leader with more than 10 years of experience and 40+ direct reports in the medical device industry under title 21 CFR Part 211 and 820 FDA/ISO 9001 environment, regulations, and compliance.
Did you require any qualifications for the role you applied for?
Yes, for my role, necessary qualifications include knowledge of good clinical practices and ICH guidelines paired with FDA regulations that govern the clinical research field.
What learning or qualifications have you gained in this role?
I obtained the certifications of ISO 27001 auditor while in Quotient Sciences as well as have been able to attend several FDA seminars.
What do you enjoy most about your role?
The constant learning about clinical research is what I enjoy most about my role. Every study is different and brings new questions that spark my curiosity to know more. I also enjoy the people I work with. They make my job purpose absolutely amazing. My amazing team is always so supportive, effective, organized, and constantly in a state of development and collaboration.
What aspects do you find most challenging?
In my field, sometimes it is necessary to align to new regulations that require rapid modifications to our processes or procedures. This poses a challenge since it needs to be done while keeping the business running. But, this is a good challenge to have!
What’s the team like?
I could not ask for a better team. Each of them shows an extreme dedication to the job, a genuine passion for what they do, and enjoyment for all of our accomplishments. I have the best team!
What advice would you give to someone applying for a role in your team?
To have an open mind. To seek to understand others’ points of view, to always be hungry to learn more, and to aspire to be better each day.
What do you like most about working at Quotient Sciences?
What I like most about working at Quotient Sciences is to know that I am making a difference in the field of medical care. To know that I took part in the development of future treatments that can save lives, and that it was done with the outermost passion, dedication, and with the best team. I love that Quotient Sciences is unique for its people and its vision!