With more than 40 years of regulatory excellence, Lifecore continues to set the standard for quality in injectable pharmaceutical and medical device manufacturing.
We recently sat down with Jackie Klecker, Executive Vice President, Quality & Development Services, to learn more about the quality function at Lifecore, the leadership attributes needed to thrive in this function, and some of the challenges facing quality teams.
Jackie began her career in a lab role before earning a chemical engineering degree. She then moved into equipment and process validation, and later, risk management. Jackie’s Lifecore career began in quality engineering, which eventually expanded to include regulatory work, client submissions, and PAI readiness, which led to her current leadership role.
How would you characterize the quality function at Lifecore?
Quality is not a standalone function; it’s embedded throughout the organization. I report directly to the CEO, which is important for regulatory visibility. Under my leadership, we have three main Quality teams: Regulatory & Compliance, Quality Assurance (QA), and Quality Control (QC).
There are also specialized teams like Quality Engineering, Supplier Quality, and Sterility Assurance, which focus on validation, risk assessments, and sterility processes. It’s a broad, interconnected system.
In the Development Services function, we use a phase-gate process for product development, supported by cross-functional core teams. Risk assessments are key for new designs or changes – no change happens without assessing unexpected consequences. We also conduct design reviews and “ready reviews” before major milestones. Quality organization is part of the team, not just a policing function.
What are some of the quality challenges that companies face?
When companies grow, particularly if they grow quickly, quality isn’t always prioritized, and leadership may lack experience. Additionally, regulations change frequently (for example, the EU GMP Annex 1, which covers the manufacture of sterile products in the EU and U.K.). Staying ahead of these changes is critical. At Lifecore, we’ve learned that growth must be matched with strong quality systems and leadership engagement.
How do you motivate teams to have a ‘quality-first’ mindset? What attributes do quality leaders possess?
I emphasize that QA is not the organization’s “police department”. Our role is to teach and support continuous improvement, not just to point out mistakes. Many on the Quality team are motivated by making processes better and delivering strong support to clients.
To be successful in quality, leaders must have high emotional intelligence and be able to work cross-functionally. Collaboration is more critical than ever.
What advice would you give someone starting a career in quality?
A good entry into an organization is to start in the QC lab as it provides a great technical and company knowledge foundation. From there, you can move into QA, compliance, or engineering roles. Focus on developing skills in risk assessment, clear/concise investigations, and collaboration. High emotional intelligence and system thinking will set you apart.