IWIM 2020 Honoree: Colleen Herczak, Grand River Aseptic Manufacturing
Like many in the health care world, Colleen Herczak’s journey into her career started with that familiar calling to make the world a better place. For Herczak, that meant venturing into the pharma industry.
“A career in pharma offers the opportunity to improve the lives of patients around the world, and a role in quality offers me the opportunity to make sure that we are fulfilling our obligations to our clients and their patients in the most efficient, effective manner possible,” she says.
Now the vice president of Quality at Grand River Aseptic Manufacturing, a pharma contract development and manufacturing organization (CDMO), Herczak utilizes her passion for understanding processes end to end, including sterile manufacturing operations, client and regulatory audits, laboratory operations, lot release, computer systems validation and change management.
As her nominator for the Influential Women in Manufacturing award says, she also leverages her position to support professional development for women in an often male-dominated field.
“Last year, she concepted and executed a female networking forum as part of her involvement with MichBio, an organization that provides advocacy and resources for biosciences professionals in Michigan. Specifically, Colleen is on the Diversity Network team which aims to champion broader diversity initiatives within the organization,” her nominator wrote. “Additionally, Colleen’s team praises her advocacy of autonomy, flexibility toward work-life balance, and ability to empower and create growth opportunities for those around her — both male and female — from top to bottom.”
Here’s Herczak’s take on what has propelled her career and what she believes is the most exciting frontier in pharma.
What has been your proudest accomplishment? If you would have asked me ten years ago if I would be the VP of Quality at a fast-growing sterile manufacturing company, or a marathoner, or a mother of two amazing kids, I would have actually (but politely) laughed at you. Yet, here I am. My proudest accomplishment is that I have never stopped challenging myself to lean into my strengths and continually redefine my goals.
What was the most game-changing decision you made in your career? After spending eight years in various Quality Assurance roles, I was in a position to take on a Quality Systems/Continuous Improvement role. That was an exciting prospect, but also a risk. I was moving out of a role in QA that I had excelled in, and into a newly created role. Making that lateral move allowed me to really apply myself in the direction of my strengths, in a much more visible way. Taking that one single risk opened the door to advancement at the site level, a global special assignment, and eventually a global role within the IT function over the next three years.
What could be the next big breakthrough in pharma manufacturing? From my perspective as a quality professional, the concept of Quality 4.0 is fascinating. Advancements in the technology around data management, connectivity and analytics have the potential to open so many doors to pharma manufacturing companies — not just in terms of outcomes, but also in terms of planning work, predicting success, gaining process understanding, and ultimately, building a culture that is firmly grounded in quality, teamwork and improvement.
What advice would you give to young women in your profession? Never, ever be afraid to ask a question. Work hard to understand as much as you can about how your business works, across all functional areas. Work hard to understand why your organization works in a certain way. The better you understand the big picture, the better able you are to anticipate issues, identify opportunities, and ensure that you are bringing your best value to the table.
Read her advice to future female manufacturers as well as the 19 other 2020 Honorees by downloading the 2020 Influential Women in Manufacturing E-Book.