✨ Introduction
In the latest episode of Career Diaries by elemed, the podcast dedicated to careers in MedTech, Elena welcomed Günter Weisshaar, Senior Vice President of Quality Regulatory at Tecan. Günter, a seasoned veteran with over 35 years of experience in the diagnostics industry, shared his insights on the critical role of quality and regulatory functions in building trust and supporting business objectives.
A Balanced Approach to Quality and Compliance
Günter emphasised a key point that has guided his long-standing career at Tecan: the importance of striking a balance between compliance and business needs. He shared his philosophy that quality and regulatory functions shouldn’t just aim for compliance but should also prioritise practical, risk-based decisions that align with business goals. “Overdoing compliance doesn’t necessarily result in safer products,” Günter noted, highlighting the importance of focusing on operational quality, supplier management, and design to ensure reliable products.
Supporting the Business: Beyond Compliance
One of the major themes in the discussion was the need for quality and regulatory teams to understand and engage with the business. Günter pointed out that too often, quality professionals are disconnected from business metrics like market share or revenue goals. He stressed the need for these teams to become more business-savvy, understanding market strategies and how regulatory decisions can impact time-to-market and, ultimately, revenue.
Günter shared a practical example from his own experience, where his team at Tecan conducted a comprehensive portfolio assessment. By evaluating the cost of bringing products into compliance under new European regulations versus their revenue contributions, they identified opportunities to streamline the product lineup, saving the company millions. This kind of strategic thinking, Günter argued, is what makes quality and regulatory functions valuable business partners.
Building Trust Through Smart Solutions
A recurring theme in Günter’s approach is the importance of building trust between quality/regulatory teams and the broader business. He discussed how his team has earned the trust of Tecan’s leadership and customers by providing smart, risk-based solutions rather than rigidly adhering to rules. Günter believes that offering multiple options to solve a problem—rather than simply saying “no”—is key to fostering collaboration and trust.
This trust, Günter explained, is evident when business leaders proactively seek input from quality teams, even on minor issues. By shifting the perception of quality and regulatory from being the company’s “police” to being partners in problem-solving, Günter has cultivated a culture where these teams are seen as enablers of business success rather than obstacles.
Communicating Value and Changing Perceptions
Günter also touched on the importance of communication in changing the perception of quality and regulatory functions within a company. He encouraged quality professionals to be more vocal about their successes and contributions to the business. At Tecan, his team actively shares success stories through newsletters and brochures, highlighting their role in achieving fast submissions, cost savings, and positive customer feedback.
For those hesitant to promote their accomplishments out of fear of appearing boastful, Günter offered simple advice: focus on exchanging experiences and demonstrating the tangible value quality and regulatory teams bring to the table. This approach, he believes, helps to build credibility and reinforces the essential role these teams play in the business.
Key Indicators of Trust (Or Lack Thereof)
Günter discussed how to gauge whether a company’s quality and regulatory teams are truly trusted business partners. He mentioned key indicators, such as whether sales teams involve quality professionals in customer presentations or if information is openly shared with the quality department. If these things aren’t happening, it may signal a lack of trust and a need for a shift in how the quality function is perceived.
Günter concluded by reflecting on what he considers his greatest achievement: transforming the culture of quality at Tecan. He proudly noted that quality is now deeply integrated into every level of the company, from frontline managers to the CEO. This cultural shift, more than any regulatory success, is what he believes will be his lasting legacy.
Self-Reflection and Initiating Change
Günter underscores the importance of starting with self-reflection to build trust within an organisation. He believes that quality and regulatory professionals need to critically assess how they and their teams are perceived. By understanding these perceptions, they can drive meaningful change within their departments. The key message is that change begins internally—transforming how the team operates and interacts with the rest of the organisation.
Tailored Communication for Different Audiences
A significant challenge in quality and regulatory roles is effectively communicating with various stakeholders. Günter emphasises that professionals in this field must adapt their communication styles based on their audience. For example, when speaking to executives like CFOs or CEOs, it’s essential to translate technical achievements into business metrics that matter, such as revenue, market share, or cost savings. This approach ensures that quality efforts are aligned with the broader business objectives and are understood and valued by leadership.
Aligning Quality with Business Strategy
At Tecan, Günter and his team have successfully integrated quality and regulatory goals with the company’s overall vision, mission, and strategy. They have broken down corporate objectives into specific imperatives for the quality department and ensured that every project supports these key goals. This strategic alignment not only demonstrates how quality functions can drive business success but also fosters greater collaboration and understanding between departments.
Building Strong Networks and Relationships
Günter highlights the critical role of relationship management in quality and regulatory functions. He stresses the importance of networking both internally with peers and externally with counterparts in other companies. Strong relationships enable smoother collaboration and quicker problem-solving, and can even open doors to new business opportunities. Günter shares examples where networking and solid relationships led to winning major deals for Tecan, proving that quality teams can directly contribute to the company’s sales and growth.
Evolving the Role of Quality
Traditionally, quality and regulatory teams have been seen as gatekeepers or enforcers of compliance. However, Günter advocates for a shift in this mindset. He believes that quality professionals should position themselves as enablers of business success, finding smart, risk-based solutions that balance compliance with business objectives. By doing so, quality teams can shed their outdated image and be recognised as valuable partners within the organisation.
Embracing a Business-First Quality Mindset
Günter takes pride in fostering a business-first mindset within his team while maintaining high standards of compliance. His approach has not only helped Tecan pass seven FDA inspections with zero findings but also strengthened the team’s reputation within the company. This balance of compliance and business focus showcases that quality teams can be both effective regulators and contributors to the company’s bottom line.
Legacy and Long-Term Impact
Beyond immediate business achievements, Günter aspires to leave a lasting legacy where quality and regulatory functions are seen as integral to business success. He wants to be remembered not only for his contributions to the companies he’s worked with but also as someone who provided value and support to others. His vision is to be seen as a giver, someone who positively impacted both the industry and the people around him.
Conclusion
These insights offer a roadmap for quality and regulatory professionals aiming to enhance their role within their organisations, emphasising the importance of adaptability, strategic alignment, balancing compliance with business needs, building trust, networking, and a business-oriented approach to quality management.
