Decades of Expertise

With over 35 years of combined expertise in Biopharmaceuticals, Hill & Hill QA works collaboratively with clients to guide quality management strategies. Our team possesses the experience to devise customized solutions to specific quality management issues and can provide stage appropriate strategies to meet regulations within the biotech, pharmaceutical and medical device fields. We understand that every situation is different and pride ourselves in working with our clients to find the most compliant solution for that situation.

Our Solutions

Our Solutions

  • Consultant/Contractor Placement

  • Quality Department Oversight

  • Supplier/vendor oversight

  • Quality Systems Development/Evaluation

  • Process Validation

  • Regulatory Inspection support

  • Pre Approval Inspection support

  • IND/NDA/BLA QA review

  • Person-in-plant activities

  • GLP / GCP audit support

  • Method Validation

  • Specification Review

  • Stability Protocol

  • Training Oversight

  • Equipment qualification

Meet The Team

Derrick Hill

Derrick Hill has had a life long dedication for working in the community that supports him. Initially, desiring to serve as a physician, he ultimately obtained a degree in Chemistry with a desire to help the community and bring biopharma awareness to under-served communities.

While honing his skills, deepening his business acumen, and identifying thoughtful client centric and employee supportive ways to approach quality assurance, Derrick began Hill & Hill Quality Associates, Inc.

In the five years since creating Hill & Hill Quality Associates, Derrick’s authentic, interpersonal approach to business has rewarded him with 3 employees, up to 7 dedicated consultants and 20+ consistent clients. He has the technical expertise, to give clients “Quality When They Need It” and an personal philosophy to give people the opportunity “create a better life for themselves”.

Daphne Smith

Daphne Smith has been practicing People Operations for 15 years as a generalist working in several industries; including accounting, philanthropy and non-profit, venture capital and biopharmaceutical.

An open, infectiously enthusiastic personality, she is passionate that seeking performers who want to use their energy within like-minded, mission-focused organizations, generates growth both personal and professional, for the individual and higher performance, unsolicited applicants and a stake in social responsibility for the organization.

Most recently, Daphne supported a venture capital health fund increase their workforce diversity to 60% with a 90% retention rate by addressing traditional recruiting approaches, people relation and evaluation practices, policies or work rules that have negatively impact BIPOC employees.

She has a B.S. from Weber State University and has maintained two Human Resource Certifications; Professional in Human Resources (PHR) and Society of Human Resource Management Certified Professional (SHRM-CP).

Tamika D. Cathey

Ms. Tamika D. Cathey is a Subject Matter Expert with over 18 years of Quality & Regulatory enforcement experience as a consultant for well-regarded international and domestic clients.

Tamika has held leadership and technical expert positions as an Associate Director of Regulatory Affairs, Charles River Laboratories; Managing Consultant, Oriel Stat A Matrix; Project Management for Dicerna Pharmaceuticals; Senior Consultant for EAS Consulting Group; and as a Consumer Safety Officer with the U.S. Food & Drug Administration.

Globally recognized for her expertise in sterile and non-sterile Pharmaceutical, Active Pharmaceutical Ingredients (API), Dietary Supplements, Biologics, and Medical Device industries, Ms. Cathey specializes in FDA compliance and remediation, centering on Quality System Design, Product release and commercialization, cGMP auditing and risk management training, inspection readiness, strategic planning, gap analysis, and FDA 483s, Warning Letters and Consent Decrees. Ms. Cathey also commands a depth of knowledge in international and domestic regulations, policies and guidance documents implemented within U.S. federal laws & regulations, International Conference on Harmonization (ICH) guidelines, EU directives, Pharmaceutical Inspection Co-operation Scheme (PIC/S) and industry standards (e.g. GMP, GCP, and GLP).

Ms. Cathey received her B.S in Biology from Greensboro College. She is a certified MDSAP auditor/trainer, obtained an Introduction to Clinical Trials certification from University of Washington, Seattle and a Biotechnology cGMP certificate from Wake Tech Community College (NC State University BTEC Program) and served her country in the United States Army. Committed to public service, Tamika assists as a Member of International Association of Professional Women, providing mentorship and guidance to foster the development of the next generation of entrepreneurial leading women. In her spear time, Tamika enjoys international travel, interior and artesian design, hiking, and reading biographies.

Haley Ali

Haley Ali is a recent graduate of UC Davis where she graduated with a major in genetics and a minor in technology management. As a student, she worked in biosafety and global affairs, and was an avid member of the business community on campus. After networking during her project management internship at Kaiser Permanente, she developed a curiosity for working in the biotech industry.

During her time as a consultant for Impact Consulting, she worked on a project related to market expansion in genetic testing, which helped her build skills in project management, data analysis, and communication. Haley is a dedicated and hardworking individual who is committed to making a positive impact in the biopharmaceutical industry.

Becca Mitchell

Currently a Senior Consultant with Hill & Hill Quality Associates, Dr. Mitchell is a 2008 graduate of the University of Arkansas for Medical Sciences College of Pharmacy and is a licensed pharmacist in 17 states. She served on the Arkansas State Board of Pharmacy from 2017-2023, including as Board President in 2021-2022.

Prior to entering consulting, she spent ten years at a facility producing sterile and non-sterile drug products, working her way from the manufacturing floor to executive leadership. She has first-chaired dozens of regulatory site audits, including FDA, DEA, Boards of Pharmacy, and accrediting entities. Becca is a solutions-oriented consultant whose focus is quality and regulatory compliance in the pharma and biopharma sectors, with emphasis on vendor oversight and quality systems that are both practical for the company’s size and applicable to the stage of development.

Gwendolyn Hearns

Gwendolyn Hearns is a Quality Assurance Manager for Hill & Hill Quality Associates. She is an accomplished Quality Reviewer with over 20 years of experience. She often uses a systematic approach to the review process to ensure her work is done thoroughly and efficiently.

She enjoys using her skills to contribute to the exciting technological advances that happens every day in the Pharmaceutical Industry. She also uses her positive attitude and tireless energy to get the work done in a timely manner. Gwen graduated from Lane College in TN, with a bachelor’s degree. In her free time, she like to walk, and when time permits, she likes to take a hot Pilates class.

Our Approach

Quality Oversight

In the Biopharmaceutical industry, quality oversight is a regulatory requirement, comprised of more than just documentation verification. Our approach is to design a compliant and pragmatic system for quality oversight. We do not believe one size fits all and strive to hear (and meet) the needs of our clients.

Product Conformance

As a component of regulatory standards, quality oversight requires a system for controlling, monitoring, and verifying any activity or process that could affect product conformance.

Full Global Alignment

From the manufacturing floor to the chairman’s office, the importance of having full global alignment with a culture of quality has never been more important as is evident with the recent regulatory inspection findings.

Contact Us

(510) 600-3902

Please call us and/or provide us with a little background info on how we can help. We look forward to hearing from you and will contact you soon

    Fostering BIPOC Career Exploration in Science

    Hill & Hill’s High School Outreach Event at Williams Lab

    At Hill & Hill Quality Associates, we are dedicated to nurturing the next generation of BIPOC (Black, Indigenous, and People of Color) leaders in science and technology. Recently, we had the privilege of organizing a high school outreach event aimed at inspiring and educating students about career opportunities in the world of science. Held in collaboration with Lighthouse Community Public Schools and hosted at Williams Lab at UC Berkeley, the event was a resounding success.

    Led by the talented team at Williams Lab, the students were immersed in a series of hands-on lab activities designed to spark their curiosity and passion for science. From DNA extraction to gel electrophoresis, each activity was carefully curated to provide students with a glimpse into the exciting world of scientific exploration. Students also had the opportunity to listen to speakers in the biopharma industry as well as practicing plant scientists. They learned about the importance of mentorship, perseverance, and self-advocacy in overcoming barriers and achieving success in science-centered careers.

    By providing opportunities for mentorship, education, and career development, we can empower the next generation of BIPOC leaders who will drive innovation and positive change in the world.

    We extend our heartfelt gratitude to Lighthouse Community Public Schools, Williams Lab at UC Berkeley, and all the participants who made this event possible. Together, we are working to build a more equitable and inclusive future for science and society.

    Stay tuned for more updates on our future outreach initiatives as we continue our mission to support BIPOC excellence in STEM.

    Careers

    Hill & Hill Quality Associates, LLC is a small boutique-firm. Derrick Hill, President left a successful career as a full-time employee to make significant impact in the BIPOC Community; to be a conduit for people to experience a substantial and or a meaningful career in the BioPharma industry. Our clients’ have told us they appreciate our integrity, personable-professional work approach, and our effort in helping them meet, often exceed, their goals. We’re always looking for intellectually-curious, intrinsically-motivated, enthusiastic teammates.

    Available Positions