Pharma Must Develop Quality Leaders: Here is One Approach

Unlike in business or engineering or medicine, advanced degrees and training in the science of manufacturing quality are not available. Yet product quality is of fundamental importance to drug companies, their patients, and the institutions that regulate them.

[Related: Interested in more from author Jerry Chapman? Download our latest FREE report featuring this and three other articles on the current pharmaceutical quality landscape.]

Efforts in the past few years by a team of chief quality officers resulted in the development of an undergraduate minor in quality to accompany a college-level science major, an important effort that provides relevant training to entry-level quality professionals. But education in the science and art of quality assurance is still needed for company leaders and executives.

AstraZeneca recently shared a comprehensive program it has established for the training and development of quality leaders, which it calls “The Modern Quality Professional (MQP) Development Tool.” At the 2021 PDA Annual Meeting held virtually in March, AstraZeneca Product Quality Group Head Stephan Krause presented the MQP tool his company developed. The tool is being used to provide a development pathway for AstraZeneca’s quality professionals and specifically its Product Quality Leader (PQL) role.

He shared a quote from AstraZeneca Global Quality Head Anthony Mire-Sluis, commenting on the importance of the MQP effort. Mire-Sluis said, “the necessity to move from the traditional concept of a compliance/checking mindset to one where we partner with the business using science and risk along with appropriate communication and leadership skills is essential to having quality built in and a quality culture throughout operations. The MQP program has not only identified the capabilities necessary but provides the relevant training and experience to achieve its aims.”

Krause also provided the company vision for the role.

“The MQP is scientific, courageous, accountable, partnering and delivering,” he said. “These attributes of the MQP can also be found in the PQL job description. The PQL works well within the CMC team. The PQL is the voice of quality in development and with the CMC teams. The PQL speaks up for quality early, takes responsibility in CMC team decisions, partners with development, and delivers to enable a streamlined development process.”

The MQP Model

The MQP development tool is intended to provide support to individuals “in their lifelong learning journey,” Krause emphasized. Underpinning it is a three-prong approach that includes a basic training curriculum, coaching and shadowing, and the repetition of core job tasks (Figure 1).

The basic training, he explained—on standard operating procedures and fundamentals of the GMP world—comprises about 10% of the curriculum. Another 20% comes from coaching and shadowing, attending conferences/workshops to learn what others are doing, and participating in discussions and networking.

However, the greatest contribution toward higher capability learning, Krause said, is learning by doing. “By repetition of routine job tasks, we learn how to do our job better. We can look for where we can improve things, where we can standardize things, and where we can interact better and more with our partners.”

He provided a more detailed look at the modules used in the “basic training” piece of the development tool. These modules comprise a directory including links to the resources the company makes available (Figure 2). Krause noted that the slide is simplified for purposes of presentation.

He explained that the training directory includes links to the various videos and documents that are part of the training curriculum.

“There are videos available on quality culture, on things that are associated with the Modern Quality Professional, and on leadership and learning. One button links to the quality capability framework. It contains a lot of the information on what it takes to reach a higher quality capability level for each quality area, such as auditing, qualification validation, quality risk management, change controls, etc.”

Because job tasks that need to be performed require different levels of knowledge about the various systems and subject matter, the company developed a set of definitions for a hierarchy of capability levels (Figure 3).

AstraZeneca evaluated the various functions that are performed by the PQL and ranked the training and knowledge required by each, resulting in capability target levels with proficiencies that map to the capability levels (Figure 4).

“We took the MQP capability areas and we picked the ones for the product quality leader that fit our job—that had relevant parts in it that we do on a routine basis, such as doing change control,” Krause explained.

“There is an area of statistics that is trending, which is needed for some of the review tasks that we do in our role of product quality reviews. We identified those, focused on those, and then we set what we thought were the right target levels.”

For example, he said, a target level of two was set for statistics and trending, and a target level of three for change control. 

The MQP program has not only identified the capabilities necessary but provides the relevant training and experience to achieve its aims

“You would need an understanding of statistics to really approve product specifications because they are typically calculated,” Krause pointed out. “To do this well, you must have some basic understanding of stats and trending. These are actionable points. Now that we have actionable points, we could now essentially establish this for all our areas that are relevant for us.”

Capability target levels were set taking into account job task frequency and criticality considerations—for example, the number and criticality of specific review and approval tasks and the potential for the tasks to impact the patient or the business.

Balancing Requirements and Training

Krause emphasized the importance of balancing requirements and the training conducted and experiences provided. 

“We can either be informed or we can be a reviewer, an adviser, or we can be the decider—it has to be one of those three,” he said. And the training and experiences provided must be commensurate with the knowledge level required and the role of the individual.

He provided a graphic illustration (Figure 5).

“For something as complex as change control,” Krause said, “you need to have an adequate level of understanding of statistics and trending as well as quality risk management.”

He commented that “it takes years” to complete enough repetitions of the change control activity to be competent. “We want to see no less than 15 change control records completed for product specifications.” The number of repetitions and time to complete them varies depending on the activity.

Soft Skills Also Important

In addition to technical competence, another key element of a successful leader is a set of attributes commonly called “soft skills.” Krause characterized that skill set as “important” and “difficult to measure.”

“For example,” he said, “How adaptable are we? How do we work with ambiguity? How often and how well are we speaking out? How can we influence others?”

“We are currently working on having similar ladders and similar progression towards these soft skills and higher levels of soft skills. But as you can imagine, it is more difficult to establish and implement.”

[Related: Click here to access our latest FREE report featuring a compilation of four articles covering the state of pharmaceutical quality by author Jerry Chapman.]