Decades of Expertise

With over 70 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).

Bhawna Gautam

Bhawna Gautam is a highly skilled pharmaceutical professional with over 8 years of experience in both sterile and non-sterile pharmaceutical environments.

Throughout her career, she has successfully managed and contributed to numerous high-stakes audits by well-known regulatory bodies, including USFDA, MHRA, EMA, Health Canada, TGA, and INFARMED.

She has a proven track record in leading and supporting key projects such as Specification/STP Reduction, publishing pharmacopeial bulletins, and implementing electronic systems like eLIMS and eDMS. These initiatives have played a crucial role in enhancing operational efficiency and ensuring compliance with global pharmaceutical standards.

With a strong foundation in pharmaceutical operations, regulatory compliance, and system implementation, she is passionate about utilizing her expertise to contribute to innovative and effective solutions within the pharmaceutical industry.

Haley Ali

Haley Ali is a UC Davis graduate with a major in genetics and a minor in technology management. Building on her early experience in campus biosafety and global affairs, she has developed a strong background in the biotech industry, spanning Quality Assurance and Project Management within GMP manufacturing environments.

She is currently advancing her education through the Global Triple Master’s Program, earning advanced business degrees across three continents via Loyola University New Orleans, SKEMA Business School (Paris), and LMU Munich. This global track deepens her expertise in international operations, supply chain, and cross-border project management.

Eric Lauterbach

Eric is a high-performing quality professional who leverages his background in GMP manufacturing to deliver pragmatic quality support. He started his career in downstream manufacturing, quickly rising to supervise TFF and chromatography processes. Eric later transitioned from manufacturing to quality and draws on his experience in both areas to provide high-quality investigation oversight, record review, and supplier qualification audits.

Eric grew up in a small town in the Sierra Nevada mountains and developed a strong appreciation for the outdoors. Outside of work, Eric spends his time mountain biking, hiking, skiing, and trying new restaurants.

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.

Natalie Zapien

Natalie Zapien is passionate about helping organizations build practical, sustainable quality systems that fit their unique needs. She earned a B.S. in Molecular Biology and an M.S. in Biology while building her career in Quality Assurance and Regulatory Affairs. With experience across pharmaceutical and cosmetic environments, Natalie helps clients navigate quality and regulatory challenges with solutions that fit their people, products, and goals.

Natalie is a U.S. Army veteran whose military experience taught her the importance of accountability, adaptability, and leading by example. Those values continue to shape her work and client relationships today. She enjoys meeting organizations where they are, understanding their goals, and helping teams make quality a natural part of everyday work.

Natalie enjoys simplifying complex requirements, empowering teams, and building confidence in quality systems. After all, building a strong quality culture should be rewarding, not overwhelming.

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.

Tell Us More

Help us tailor the best solutions for your needs by completing our quick questionnaire.

Contact Us

(510) 600-3902

846 Whipple Road, Suite A, Union City, CA 94587

    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