Director of Quality Assurance for Research and Development (Retired)
Quality Assurance Department
Corona, CA, USA
Field: Pharmaceutical Quality Assurance
Elsa Gomez, director of quality assurance for research and development within the Watson Pharmaceuticals, Inc. Quality Assurance Department, began her career as an auditor of companies that provide pharmaceutical products to the United States Department of Defense. By being involved in all aspects of pharmaceutical manufacturing and all of the associated quality control systems, she gained the necessary experience to fulfill her present-day role. Since her employment with Watson Pharmaceuticals, Inc. fourteen years ago, she has helped to grow the quality company – which produces generic pharmaceuticals and specializes in pain relief medications and oral contraceptives – from 80 employees to more than 1200.
As a quality assurance professional for one of today’s leaders in the generic pharmaceutical industry, Ms. Gomez stands by her word by providing affordable, high-quality pharmaceutical products that will enable people to effectively manage their health conditions. She asserts that doing her job effectively requires that she listen to others’ points of view in an objective and open manner. “I don’t micromanage,” she elaborates. “I give them the assignment and leave myself open to their questions.” She oversees the quality assurance oversight of the research and development activities of the company’s pharmacists and chemists while ensuring the use of proper manufacturing practices in the internal research and development department according to regulatory agency guidelines. “I ensure that the appropriate quality systems are in place and that any information and documentation submitted to regulatory agencies meets current requirements,” she states. In addition, Ms. Gomez assists managers and employees in the research, development and quality assurance departments, and prepares for regulatory agency inspections as needed.
Ms. Gomez received a Master of Science in chemistry in 1972 and a Bachelor of Science in chemistry in 1967 from the University of Puerto Rico. She is a member of the American Society for Quality and the American Chemical Society.
In her spare time, Ms. Gomez enjoys reading history books, traveling and studying archeology. She reads Pharmaceutical Technology, Chemical & Engineering News and Quality Digest.
Conversation with Elsa Gomez
Worldwide Publishing: What would you like to promote most about yourself or your business?
Elsa Gomez: We provide affordable medication to the public. As the director of quality assurance for research and development, I like to work with people. One of the things I enjoy doing is getting the best out of my clients.
What is the most rewarding aspect of your career?
Being able to help create a viable company. We started with 80 employees and now we are above 1200 employees. It is rewarding working with them and assisting them in reaching their goals.
On what topic(s) do you consider yourself to be an expert?
Manufacturing processes and the implementation of controls for these processes to meet regulatory compliance requirements.
What is your greatest professional accomplishment to date?
Having established and created a quality organization within Watson Pharmaceuticals, Inc.
How do you remain current in your profession?
I read quality-related and pharmaceutical manufacturing journals that offer new techniques. I’m also a part of the American Society for Quality. I attend conferences and seminars given by regulatory agencies and the pharmaceutical industry to keep current on training and regulation changes.
What are your short-term and long-term career goals?
My goal is to retire in three years and consult.
What is the most significant issue facing your profession today?
Continuing to provide affordable medication.
What is the most difficult obstacle or challenge you have faced in pursuit of your goals?
The training, which involves getting all of the people in the organization to understand regulatory requirements and the reasons why they are in place.
What advice can you offer fellow members who work in your industry?
Be very open to ideas and what people recommend. That doesn’t mean you accept everything; you question why they’re doing this and recommending that. This is how you learn.
We’ve been doing things the same way for 10 years. All of a sudden, someone comes in with an idea that would reduce the amount of work that needs to be done by half. If you can put it in the right checks and balances, you are still meeting your compliance requirements, but you’ve improved the process. You can’t be closed to new ideas. Always be open to learning and to new ideas.
What are you passionate about?
Traveling and getting acquainted with the world. There are so many different things. I have a very good life; I don’t have any complaints. But there are other things out there that we can see, and from which we can learn. We don’t have to like it necessarily, but continuous learning is important.