Industry Leaders: An Advocate for Quality

Pathak’s career journey has been one of constant evolution and considerable movement around the globe. The worldwide scope of her career may have been inspired in part by her father’s career as an airline pilot, which enabled her to travel frequently during her childhood in India. “My dad encouraged me to study computer programming, but I wanted to leave India. I felt I was somehow a generation ahead. Around age 20, I didn’t have any specific ambition other than to have a different life. I wanted to live where I could get music and chocolates easily!” It was this enthusiastic desire for novelty and change that brought Pathak to the United States in 1980 on Thanksgiving Day.

Pathak enrolled at a small data programming school in New Jersey, where she studied the computer language COBOL for six months. Following Indian cultural tradition, she entered into an arranged marriage soon after.

Early in her career, she was “bored to tears,” she noted. “My computer programming background wasn’t working out. I had studied COBOL and RPG II, but companies wanted Fortran. So I needed a new plan. I wanted to be back in control of my life.” Following a friend’s suggestion, she shifted her focus to chemistry and began working for a small pharmaceutical firm in Long Island, New York, where she was the only woman.

Following the birth of her first child in 1984, Pathak felt increased financial pressure. Realizing the limitations of the local pharma industry and the high cost of living in Long Island, she resolved to learn more to provide herself with more options. “I studied the U.S. Pharmacopeia. It’s a fascinating book. I would study the chapters at home, and I realized how much I didn’t know.” Pathak described the challenges of raising her children while building her knowledge of the pharmaceutical world, balancing the roles of mother and professional.

“I was cognizant that I had only an undergraduate degree in chemistry. It was an honors degree from a good college in India, but I really wanted a US degree. I was driving in Long Island when I saw a sign on the back of a bus. It said, ‘Why follow when you can lead?’ It was an advertisement for an executive MBA program. I thought, ‘I’m already in my late 30s. But hey—why not?’ I applied, and it turned out my employer would pay for it. I was working full time as a lab director and attending an all-day MBA program from 7:00 a.m. to 5:00 p.m. on Saturdays.”

Later, Pathak spent four years earning a doctorate in health administration in her late 40s—again while working full time in a demanding position. When she graduated, her two adult children, both of whom are board-certified physicians, were in attendance. In her mid-50s, she made yet another intercontinental move, returning to India to care for her father while embarking on the next leadership role in her pharma career.

Agility as an Art Form

“I wanted to be a Bollywood actor when I was young,” Pathak said, referring to the Hindi-language film industry based in Mumbai. She noted that her early training in Bharat Natyum, a form of dance that emerged out of millennia-old temple traditions, gave her confidence, poise, and patience—qualities that have helped her navigate her complex and varied career. “You can’t dance if you don’t have confidence and courage,” Pathak commented. “You’re taught how to face an audience.”

Dance also taught Pathak intuition and perception, which she uses to understand the human elements of achieving quality in manufacturing. “I firmly believe that people are at the heart of any operation,” she said. As a dancer, “you learn to be attentive and convey ideas with more than words. In dance, there are usually two parts: There is movement itself, but there is also a story. It works across cultures. It allows us to connect without words. You don’t have to translate smiles or tears.” Similarly, in industry, “Culture is the foundation for quality. It includes the mindset of the leader and the worker. The culture has to be such that everyone understands the meaning and principles of quality. Quality is hard to quantify, but it can be felt and experienced. It is often unwritten and unspoken. People are intelligent. They can hear, but they also can sense what leaders are and aren’t saying.”

People and Planning

In the pharma industry, Pathak believes that “the quality of a product is intertwined and interlaced among various disciplines—R&D (including clinical groups), regulatory affairs, technology transfer, routine manufacturing, quality assurance, quality control, and, finally, life-cycle management.” Facilitating this interplay requires intentionality and planning, beginning with the acquisition and development of talent.

Pathak emphasized the importance of ensuring that the people hired in the industry have the mindset and training to execute their jobs. “Learning and training should be at the core. In today’s ‘war for talent,’ it is difficult to hire and retain talented people. Hence, the onboarding process must be robust. This is where companies have to invest in employees,” she noted. “It’s not a one-time investment; rather, it has to be a continuum because these are the people that will make or break the company. The onboarding program should aim to equip people with an understanding of the ‘why’ behind doing things right, and the implications of not doing so. Too often, our bias is to emphasize only ‘what’ we do. But to ensure quality, people have to understand the ‘why.’”

Clear Processes and Product Ownership

Having the right people is essential, but without clarity of processes and procedures, true quality is out of reach. Pathak offered some advice in this regard. “Procedures must be specific and clear. They must be written in language that people understand. It’s best if these directives are written in collab-oration with those expected to execute the tasks. Procedures also should be as simple as is feasible, with clear work instructions, job aids, visuals where possible, and flowcharts that illustrate process.”

Quality also requires a sense of product ownership across all aspects of manufacturing and among the various departments. “The people touching the product are most important. Companies must invest in this cadre. While these jobs are routine, they are not mindless. Individual leaders cannot take their eyes off the process. There should be mechanisms in place to continuously judge the ‘fitness for use’ and course-correct based on results,” Pathak emphasized. When stakes are high and numerous variables have to work in tandem, pharmaceutical companies require “trained staff, open communication, and a quality mindset among everyone.” In other words, “People at every level of seniority, at every stage of the process, must share the same high sense of pride and ownership of the product. Leaders have to nurture this.”

The Value of Diverse Perspectives

As a leading woman in the pharmaceutical industry, Pathak has both subjective and objective insights concerning gender dynamics in organizations. “It is not my bias that leads me to say that women bring a different point of view. Diversity is critical for problem-solving. By nature, there are innate and inherent differences between men and women, and these differences can enable better outcomes,” she said. “Constructive dissent can lead to better conclusions. Often there is ‘group-think,’ and domineering men will take over the conversation and decision-making. This hurts companies because the perspective is not balanced. It is important that companies foster an environment where views coming from a minority voice (often that of women in the leadership ranks) are not looked down upon.”

People are the foundation. People innovated the products and processes. People made the plans. People have surmounted the challenges of the past, and our call to action is to work collectively on the quality journey. We need to keep quality at the forefront of both thought and action.

Pathak offered specific insights about the benefits of women’s perspectives. “As a woman and a mother, I know that I am very tolerant and understanding of problems that occur. Women seem to have a ‘sixth sense’ that helps us understand the human elements at work in situations.” She commented on how society at large, including government and educational systems, can work to eliminate barriers that prevent women from contributing to leadership in various industries. “Mentoring programs are key, and building them right means engaging female mentors as well as male mentors who are both sensitive to gender differences and genuine believers in the benefits of female leadership. Once this is started, it can spread like wildfire. It’s also vitally important to promote women based on their skills, so as not to cause reverse discrimination.”

Ultimately, Pathak believes gender dynamics within organizations have to evolve to ensure genuine appreciation of what both women and men can offer. “Companies have to be able to harness the inner strength a woman brings. Passion and commitment are women’s strong suits. Structured programs and academies can help them rise to the top.”

The Future of the Quality Journey

Asked what excites her most about the future of the pharma industry in the context of quality, Pathak focused on closing the gaps between regulatory bodies and industry players. “Those gaps are starting to shift in the right direction by becoming narrower. Part of the issue is that too often, the dialogue between regulators and industry is perceived as too daunting. I am all for punitive measures when there is clear evidence of wrongdoing, but I would like the quality journey to be such that the default line of thinking is not punitive. Rather, it’s focused on mutual improvement of products and services.”

Pathak explained that she is especially excited by recent innovations. “Novel technologies have emerged, whereby the previously unthinkable is happening—such as using our own bodies to heal, as is the case with chimeric antigen receptor T cells (CARTs). Innovation like this excites me and needs to be encouraged by academia and government; companies cannot bring these technologies to their full potential alone.”

She went on to offer her thoughts about pharma’s impact on society. “Making medicine should be one of the most gratifying industries. I feel grateful for being able to play a small role in it. Pharmaceuticals have done a lot of good—increased longevity, reduced infant mortality, eradicated diseases such as a smallpox, and improved quality of life for those suffering from chronic diseases such as diabetes.”

Despite these advances and benefits, Pathak emphasized the importance of relentless efforts focusing on quality pharmaceutical manufacturing to face challenges old and new. “We are also seeing a resurgence of disease and the emergence of ‘superbugs.’ We need new therapies; otherwise, we could find ourselves back in the early 19th century, when a common cold could be fatal.”

Pathak commented on the importance of ISPE and the resources it brings to bear in the industry. “ISPE is an industry knowledge hub—a place where expert knowledge is shared. I always look forward to reading the papers and reports based on the strong body of research conducted over the years.” She urged Young Professionals to get involved in their local Chapter or Affiliate. “My strong recommendation for those serious about their profession in pharma is to join ISPE and participate actively in the meetings. This is particularly true for Young Professionals. It is a great place to learn, connect, and look for support for old and new topics.”

As we wrapped up our conversation, Pathak returned to the themes of people, products, processes, and plans, encouraging others to make a commitment to these four prongs of pharmaceutical progress. “People are the foundation. People innovated the products and processes. People made the plans. People have surmounted the challenges of the past, and our call to action is to work collectively on the quality journey. We need to keep quality at the forefront of both thought and action—without that, nothing will survive for long. I encourage every one of us in the industry, regardless of our roles, to see our essential part in the quest for quality. We have to make that quest part of our professional DNA.”

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