Assuring quality at every step

For Shay Tabani, the patient is always her top priority.

She’s not a doctor or a nurse, but as vice president of quality assurance for Sorrento Therapeutics, a biopharmaceutical company in San Diego, her job is to make sure the medicines made by or on behalf of Sorrento meet the quality standards they purport to possess and are fit for their intended use.

“We are all focused on the same goal—that the medicine going to the patient is safe and effective,” she said. “When it comes to medicine, it is not like buying a coat at Macy’s or Nordstrom, where you can return it if there is something wrong with it. It can be a matter of life and death, so it has to be right.”

That is no easy task because Tabani must oversee every aspect of the quality program at Sorrento to assure that every production lot manufactured by or on behalf of the company complies with regulatory mandates from the state as well as the Food and Drug Administration. She also must detail and review the procedures not just at Sorrento but also for Sorrento’s suppliers and service providers.

“Quality assurance is looking at the dynamics of every single step of the process, from start to end, to ensure it meets acceptance criteria and that the right policies and procedures were followed to manufacture the drug or biological product,” she said.

While that oversight might seem daunting to some, Tabani enjoys the challenge and works hard to stay abreast of the constantly changing regulatory field.

“Learning never stops,” Tabani said. “Every day I go to work I learn something new.”

Tabani, who received her degree in chemistry from the University of Karachi, got her professional start working in quality control for Peregrine Pharmaceuticals/Avid Bioservices in Tustin. Her constant critique of systems and processes prompted her boss to tell her she should move over to the quality assurance side of the business, where she could design the procedures instead of testing them.

“I was always going on about all the things that were wrong and how the existing processes should be improved,” she said with a laugh.

To make that switch, she joined several professional organizations, including the American Society of Quality, and also participated in seminars, workshops, and other continuing education courses. One such course was the certified quality manager exam preparation course, which Irvine Valley College offered as part of its quality management professionals program. Tabani said that program as well as UC San Diego Extension’s regulatory affairs and quality assurance and control certificates are invaluable to anyone interested in the field. While at Avid Bioservices (then named Peregrine Pharmaceuticals), she recommended to her teammates that they take courses at Extension to improve their knowledge of the regulatory industry.

“It made a difference in both their performance and confidence,” Tabani said.

Now at Sorrento Therapeutics, Tabani said she often struggles to find the right people with the relevant skillsets because many coming right out of college don’t have the proper industry training to be able to immediately start work.

“There is a gap between academics and what the industry needs,” she said. Because of that, Tabani said those with certificates from UC San Diego Extension have an edge when it comes to being hired.

“If it is between a person with a bachelor’s degree and a person with a bachelor’s and a certificate, I will always pick the person with the certificate because I know they will have the relevant knowledge,” she said.

But a career in regulatory affairs is about more than knowledge. It is about having the right perspective and attitude about the work, Tabani said. She looks for people who are meticulous and conscientious but who are also team players.

“I want to hire people who can get along and are not there to ‘get’ people, but who are there to do the right thing and to help people,” she said.

That is particularly important with the work Sorrento Therapeutics is doing to develop treatments for cancer and the pain associated with it to help address unmet medical needs and improve the quality of life of patients.

“For anyone who has had a family member or friend with cancer, they know how difficult it is for the person suffering and how difficult it is to watch the suffering,” she said.

Because of that mission, Tabani takes her job seriously and has tried to instill that commitment to her three children.

“My kids have seen me work all these years, and I have always told them working hard is just not enough: honesty, integrity, and the passion to do the right thing must be integrated into each and everything we do. When you look at yourself in the mirror, it should not be hazy but clean and clear” she said. “It should always be clean and clear.”