India-problems require India-solutions. The case of the pharmaceutical industry in the country is no different. Catering to well more than 140 crore people, the country's healthcare needs are as unique as it is extensive. Intrinsically, the situation calls for strong leaders with excellent foresight. Dr. Birendra Singh, the President & Global Quality Head of Mankind Pharma—one of India’s leading pharma companies—joins us for an exclusive interaction. Well-known for his inspirational approach to leadership, Dr. Birendra has a proven track record of excellence in the industry. He has an extensive experience of working with regulatory bodies across the world. Below is an excerpt from the interview.

How can QA leaders set the right vision, goals, and direction for their organization's quality programs today?

Let's take the case of Mankind. The quality organization at Mankind is driven by qualified and seasoned professionals who are involved in defining the organization's quality policy. Our core values, such as Customer Centricity, Quality, Innovation, Integrity, and People Development and Collaboration, are all woven into the Quality Policy. It is the apex document that is fundamental for setting up Quality Objectives. Communication is the key to achieving organizational goals and objectives. Therefore, Quality Policies and Objectives, along with the organization's Core Values, are communicated to each employee. Quality Management Leadership organizes various employee engagement programs such as Training, Workshops and Rewards and Recognition with a view of percolating the Vision, Goals and Direction of the organization along with Quality Policy and Objectives. Quality culture and achieving excellence are the ways to move forward in any organization and top leadership.

How do leaders drive digital transformation across operations to meet the highest global quality standards in the industry?

In the era of Industry 4.0, all industries are moving to automation and digitization of their operations, such as manufacturing, engineering and supply chain, to enable real-time, data-based, and informed decision-making. Quality acts as one of the enablers in this process. For instance, we at Mankind are automating and digitizing the Quality Systems and Quality Processes integrated with other digital platforms linked with operations, engineering and supply chain. Having all the necessary information and data integrated facilitates scientific, quick and real-time decision-making in the interest of the organization and our customers.

The leadership in quality has taken a leap in this direction by implementing various digitization initiatives that include the implementation of a Digital Document Management System, Digital Training Management System, Digital Quality Management System, SAP HANA, and other digital applications in our laboratories like LIMS & eBMR, and eLog-book at manufacturing. In a journey of quality excellence, the quality of operations is being further automated and digitized by automating our laboratories, quality systems, plant operations, and engineering operations.
 

This involves clear communication of the goals of the organization, putting the right people at the right job, motivating people, explaining to individuals and teams the advantages of collective and unidirectional efforts and creating an environment of win-win situation

How do we identify opportunities for improvement and addressing quality issues?

The collective force and energy projected in the same direction are needed to achieve excellence. Leaders play an important role as the driving force that synchronizes and channelizes the goals of an individual as well as the organization. This involves clear communication of the goals of the organization, putting the right people at the right job, motivating people, explaining to individuals and teams the advantages of collective and unidirectional efforts and creating an environment of win-win situation. The leader should engage with people at all levels through GEMBA Rounds, Town Hall Meetings, One-on-one meetings, Training, Workshops, Reward and Recognition Programs, promoting Speak-up Culture and, more importantly, obtaining feedback. A leader should be able to look for subtle signs while engaging with people and identify the similarities and differences between individual goals and organizational goals.

Having done this, the synergy created will itself work in the intended direction. Developing a culture of "Speak-up" coupled with empowerment will work as a proactive measure to address quality issues. Traditionally, the quality of a product in the pharmaceutical industry was based on testing and compliance with specifications or pharmacopoeial monographs. It was based on "purity". There is a paradigm shift in pharmaceutical quality systems and pharmaceutical product quality with enablers like ICH Q8, ICH Q9, ICH Q10 and ICH Q11. We now talk about impurity from purity and look at building quality into the product while designing/developing a product rather than ensuring product quality at the end of manufacturing by testing. The other thing that can be done is to look for lead indicators such as Out-of-trends, Deviations, Incidents, CAPAs etc., rather than lag indicators such as OOS, complaints and recalls.

For instance, Mankind has various initiatives to constantly improve our quality culture. One such initiative is “QbX” (Quality by Excellence). This initiative was launched across all sites of the organization. The program is built on five pillars: people development, infrastructure development, digitization, process improvement, and cost and productivity improvement. This program further underscores that quality leadership is aligned with the vision, goals and core values of the organization. Although this knowledge is available in the public domain, the key here is to reinforce it systematically and establish a measurement mechanism and KPIs aligned with the organization's overall goals. Any and all organizations can run such initiatives to bring their people together to build a quality culture.

Tell us about your leadership approach.

I believe in a people-centric approach. While the product, process and procedure are other pillars essential for achieving growth, success and excellence, people are the core of all these. In the current era of Industry 4.0, digitization, AI, ML, IoT, etc., are utilized to collect data, analyze it, and make decisions. However, all these are enablers that are eventually designed and developed by people with the objective of easing human efforts and reducing human errors. Therefore, we should focus on keeping people at the core of everything. We should look at developing people and people’s competencies.

Despite many global studies, countless books written on the topic, and establishing several schools of thought on leadership, there are still no sure-shot guidelines or methodologies that can be used for demonstrating leadership. A leader deals with people living with their own world of thoughts and full of emotions that change with time. Each individual is different; their socio-economic background, training and education are vivid, their needs are diverse, their motivation levels are different, and their objectives are different. Therefore, as a leader, we should coach, mentor, and empower them. We should empathize with people and motivate them, should be able to understand the individuals, their actions, and their behavior in the surrounding social context and should be able to support them in their growth journey.

What would be your advice to budding leaders in the quality domain?

I have learned that quality is built into the product and processes on the shop floor. Quality culture is the way of life in the pharmaceutical industry. Enhancing people competencies, continuous improvement, and adherence to health authority regulations make you more competitive in the industry. While management devises overall organizational goals, vision, mission and objectives, it is the shop floor in Manufacturing, Quality Control, Quality Assurance, Engineering, Warehouses, Distribution chains etc., where the quality and value get created. Therefore, the leaders should keep engaging with people on the shop floor. The voice of the shop floor should be considered while decision-making as that is the place where solutions to the problems can be found and addressed proactively. Last but not least, patients. Our customers should be considered because we are in the business of manufacturing lifesaving drugs for patients in need, and we are responsible and accountable for their health, safety and well-being.

 

Hobby:  Reading books related to Medicine and Investments

Favorite Cuisines:  Indian cuisines like simple veg foods along with raita

Favorite Movies: Slumdog Millionaire

Favorite Books: The Psychology of Money, Organon of Medicine

Favorite Travel Destination:  Blue Moon Valley, Lijiang, China