Culture. It’s a term many companies use to encourage a respectful, inclusive, and progressive environment. Various programs are conducted to guide leaders, empower fellow employees, and organically encourage mutual growth. But what defines a culture that revolves around quality of biologics, ones that eventually serve the basis for medicines reaching the bodies of patients?

“We can strategically manage quality operations at Samsung Biologics because we have manufacturing and development facilities all in one site,” said Hyunjin Choi, Director of Client Quality. She remarks that harmonizing is what her team does – while plants and facilities can be separated and each plant has different characteristics, the role quality professionals play in the company permeates the broader culture.

Quality teams can also be a proactive partner within the company, informing other teams of how processes are run in faraway corners of the organization. “Each team may not always be aware of what each another is doing, whereas quality teams can see what each plant is doing, for example,” said Alex Jung, Senior Director of Quality System & Compliance. “This is like how we can see that status of each project, thanks to the robust database we have built from a track record of serving biopharma companies around the world.”

“A quality culture trickles down, but it is also baked into each level,” said Samsung Biologics’ data compliance expert. To encourage a culture of reporting deviations or other inevitable instances of human error, employees need to be assured that there will be no penalties. An anonymous reporting system, for example, helps bring such issues to immediate attention.

Constructive course correction

Since 2012 when Jung first joined Samsung Biologics, appreciation for quality teams from other departments has grown – and so have expectations. “Quality is everyone’s shared responsibility. Whereas agility is already part of our DNA, when quality is lacking, it is detrimental not only to the company but more so to those we partner with and serve,” Jung said. “Quality is a non-negotiable.”

Hand-in-hand with speed, another strength of Samsung Biologics as seen by the data compliance expert is execution. “This means we can correct course fast,” they said. 

Encouraging ownership

To Eunah Yoh, Director of Client Quality, shedding light on the client’s perspective for her team members from a bird’s eye view is how she offers clarity in times of potential uncertainty. “By adding two more lines of explanation to the originally single line, I seek to explain the background of a given task in detail,” Yoh said. “We can move forward together once the purpose and background of a task are fully explained and aligned on.” 

Giving challenging but fruitful work is how Jung motivates his team. “Creativity is an important trait prospective members should have,” he said. “Rather than passively following given procedures, discerning which is the more efficient and effective path to take is a skill.”

Sustaining a quality culture that encourages employees to take ownership of their work means employees need to grow together. Such passionate ownership seen in junior specialists is one reason why the data compliance expert comes into work. “Ownership, responsibility, passion – leaders need to show this first,” they said. “Then, positive influence spreads outwards.” 

Training and education along with technological tools to reduce human error are how Samsung Biologics proactively nurtures a quality culture. Using digital media and the internal company portal, the webzine format was used to reach employees and share case studies. An opportunity to study trends and stay vigilant about data compliance, the initiative is evolving to be even more personalized so that it is impactful to each individual. “If the individual has no personal motivation, external accountability alone cannot create it,” the data compliance expert said.

Come full circle

To Choi, thinking about how the medicines can potentially reach her own family members is what drives everyday decision-making. “Separate from being the director of a team, I am just one individual,” she said. “Beyond being able to have experiences in Samsung Biologics that they cannot at other companies, building a career in the quality space within biopharma can be rewarding in and of itself and I try to share my own experiences with my team.”

“Data compliance means a lot to many people,” the data compliance expert said. “It’s the reason I have invested my entire life in the industry and why I would like to see people feel a personal responsibility to actually see they are making a difference.”

A quality culture at Samsung Biologics, while continuously maturing, is built on the experiences the company has accumulated since its founding. “I would ideally like those on the frontlines to proactively create a quality culture going forward,” said Yoh. “In addition to related awards, reminders in the form of wall graphics, and custom screensavers, it is the voice of the employees themselves that builds clients’ trust.”

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