Introducing Gilero’s New VP of Quality & Compliance
Hope Tuck is the newest addition to Gilero’s leadership team. She joins Gilero with over 25 years of experience in the medical device and pharmaceutical industry. As the new VP of Quality & Compliance, Hope provides support and leadership to our Quality team, ensuring Gilero’s projects are compliant with all its necessary requirements and documentation, and are safe for our patients.
What was your career experience prior to joining Gilero?
For the past 25 years, I have held various positions in medical device and pharmaceutical development and manufacturing. For medical devices, my experience includes automated assembly, injection molding, auditing, systems automation, and improvement. My pharmaceutical experience is spread across multiple dosage forms and indications. I have had increasing responsibility for quality systems, quality operations and development roles for biologics, small molecule, and vaccine products as a contract manufacturer, managing contract organizations as well as internal programs.
What is your Quality experience as it relates to medical devices?
I began my career in medical devices as a product support engineer for a vision correction laser company. That organization was pursuing ISO certification and I was responsible for writing the SOPs needed to achieve that goal. I loved working with the quality team and eventually managed the team. After that, it was QA (Quality Assurance) all the way. My next role was as a Quality Engineer for a company that designed and manufactured needle-free components for infusion sets. I have recently been involved with some combination product development which is an exciting intersection of my experiences.
What led to you choose a career in Quality?
Quality provides the guardrails to keep the patient in mind for every decision. I love root cause analysis, risk mitigation, and strategic planning. Quality has provided me with a positive vehicle to improve the lives of patients and their caregivers with collaborative approaches to quality. Being a partner and coming up with impactful solutions to opportunities throughout my career have confirmed that QA is the right place for me. I operate under a “Make Each Other Better” mantra ensuring QA is a partner for the organization.
Why come to Gilero?
This role at Gilero is a full-circle thing for me. My experience in pharma and devices aligns perfectly with Gilero’s mission and values. The leadership team is amazing and quality culture minded which facilitates alignment across projects and allows us to figure out things together. This cooperation ensures stakeholder involvement across the organization to come up with the best solutions. I also had the pleasure of working with Ted at a previous company at the beginning of our careers, so it’s nice to be back together and working with familiar faces.
Why is having a robust Quality system so important in the Medical Device and Pharmaceutical industries?
In both the Medical Device and Pharmaceutical industries, the mantra is if it’s not documented, it didn’t happen. So the quality of your documentation and the quality of your programs is important. Regulatory agencies will typically draw a conclusion about your organization within hours of arriving for an inspection. The same is true of customers. Having a compliant, sustainable quality system is key in demonstrating control, and integration of tools to consistently meet regulations. This improves the patient experience and gives Gilero and our customers confidence in our expertise and abilities to consistently deliver. Luckily, it also makes good business sense!
What are you looking forward to accomplishing in your new role?
Collaboration, Compliance, Continuous Improvement, and Celebration! Getting to know everyone and finding out what they’re passionate about so they can continue to grow and succeed is one of my top priorities. I hope to continuously improve the Gilero systems to support successful, compliant projects. Automating several key quality systems is important for our overall growth. Working smarter with sustainable systems is goal one!
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