Regina Gueren Lombardi '91 - Alumni Spotlight

Regina Gueren Lombardi '91 serves as the Head, Quality Systems and Operations, for Sanofi U.S. LLC – North America, a leading global pharmaceutical provider. This is the latest stop in her long career in the pharmaceutical industry, one whose roots can be traced to Mr. Spahrmann’s Chemistry class in 1989. Regina is forever grateful for her time at St. Edmund and credits her teachers and the education she received here, for instilling core values which have made her a productive colleague and leader of leaders in the workplace.

 

Growing up in Marine Park, Regina recalls St. Edmund as being the center of her life.  She attended the grammar school and received her sacraments at St. Edmund Church.  She has many fond memories of the neighborhood.  She and her sisters Lisa Marie and Donna followed the same course until high school where her sisters attended public high schools. Alternatively, Regina approached her parents, Richard and Dolores, asking if she would be able to attend St. Edmund High School which she thought would better fulfill her academic pursuits.  Her father was a fireman and her mother served as an administrative assistant.  She recalls they immediately responded yes to her request, without questioning the financial sacrifice the family would have to make to send her to St. Edmund.  Her parents had always stressed the importance of education, especially as a tool of empowerment – to excel in life and to make a difference in the world. Regina was ambitious and yearned to learn.  She knew St. Edmund would allow her to excel. 

 

Regina loved her high school experience and availed herself of every opportunity. She was editor of the yearbook, member of the National Honor Society, Student Council, the boosters, science club, the culture club, to name a few. A number of faculty members made a great impression on her, shaping her thinking, challenging her mind and honing her leadership skills.  Mr. Spahrmann had an innate ability to put the most difficult chemistry concepts in layman's terms.  His teaching methods allowed students in his class to find chemistry relatable and understandable.  She credits this class as a prime motivator in her love of chemistry.

 

Sr. Rosemarie Figlia taught religion and moderated the culture club which exposed her and many classmates to the iconic cultural treasures of New York.  The group would travel to Manhattan to explore museums, sample restaurants, and it was Sr. Rosemarie who brought a number of the students to their first Broadway play. She was instrumental in teaching the important of honoring the soul and exemplifying Christ in words and deeds each and every day of their lives.

 

Regina credits Sr. Barbara Doyle, CSJ with instilling the importance of integrity - how important it is to honor your word and commitments.  If you cannot honor those commitments, Sr. Barbara encouraged the students to seek assistance from those around you, find the resources available to overcome obstacles, and be accountable.  “Say what you mean and mean what you say,” words which are incredibly important in building character.

 

Mr. Raffaele (“Ray”) Malafronte, a passionate English teacher and spiritually-centered individual shared his love for reading and he strived each day to be instrumental in opening up young women’s minds to the beauty, symbolism and lessons found in English and American literature.

 

When Regina reflects on her St. Edmund High School years, there are three lessons which have informed both her personal and professional life:

 

Regina served as Valedictorian of her class, and armed with a full scholarship, headed off to St. Joseph’s College in Brooklyn to pursue her love of science. As a chemistry major, Regina recalls uneasiness about what avenue she might pursue after graduation.  There were thoughts of forensics, nursing or pharmacy, but none seemed to instill a spark in her.  She approached Sr. Mary Maier, the chair of the chemistry department and asked for guidance.  Regina wanted to work in her field with the hope that such a position would help her determine where to best utilize her talents and lead to a career upon graduation.  Sr. Maier and Corinne Gamper ’75, a fellow St. Edmund High School graduate and St. Joseph's College alumna were instrumental in the commencement of internships between St. Joseph and Pfizer Inc.’s flagship manufacturing facility in the Williamsburg section of Brooklyn, neighboring establishments only a few train stops away from each other.  Regina interviewed for and accepted an offer to work after school in the In-Process Quality Assurance department in the beginning of her junior year.  It was an immersion into the world of pharmaceuticals and Regina was quickly learning the importance of equipment validation protocols, equipment installation and performance qualifications, laboratory testing, as well as the importance of standard operating procedures in a world class pharmaceutical manufacturing and packaging environment. Most importantly was the unfolding of the beginning stage of being a part of producing quality products that transform lives for those with unmet needs. Little did she know that Pfizer would be her career home for the next twenty-three years.  Regina recalls Pfizer’s rich history of excellence, innovation, and discovering scientific solutions.  Working at a company that was driven by eight core values of integrity, respect for people, customer focus, performance, innovation, leadership, teamwork, and community was a blessing, for it served as an environment that was consistent with the values instilled in her during her formative years.

Regina recounts her career in three phases. The first ten years were spent in the Quality Control department; she championed activities in various roles, including the development of control documents, coordination of site investigations and responses to consumer product quality complaints, the testing and evaluation of batch/lot test data, ensuring compliance to standards, and verifying that environmental conditions were acceptable for producing and storing product to name a few.  She needed to be informed on not only the FDA regulations and requirements, but also diverse global agencies which regulate the pharmaceutical industry - all the while moving up the ladder in the manufacturing plant. During the 1990’s, Pfizer was acknowledged with unprecedented success in marketing products as leading medicines in their therapeutic class.  Best selling drugs like Norvasc (number one antihypertensive), Diflucan (a leading antifungal), Zoloft (the world’s second largest selling antidepressant), Zithromax (the most prescribed brand-name oral antibiotic in the United States), and Viagra (a revolutionary drug for erectile dysfunction) were all manufactured and launched out of the Pfizer Brooklyn plant!  Regina had the career milestone of reviewing and approving the first batch of Viagra for consumer use and spent many years as a member of the plant Quality Operations team.

The second phase of her Pfizer career sent her to Peapack, New Jersey for twelve years where she gained expertise in Regulatory Chemistry, Manufacturing and Controls (RCMC) as both an individual contributor and Team Lead.  Here she learned the ins and outs of the corporate world, management of the Established Products Business Unit portfolio, served as the point of accountability for CMC product knowledge, and effectively strategized regulatory pathways in the pursuit to commercialize products. As a responsible expert in the oversight of product registrations and scientific dossiers, she authored necessary documentation that was filed with health agencies around the globe, ensuring that the drugs and the corresponding product file met agency expectations for not only first time approval, but also continued license maintenance in various markets.  She learned a great deal about behavior in the workplace, “best-in-class” practices, in sustaining focus on performance, managing change, identifying deficiencies and opportunities, improving customer satisfaction, and developing people. After serving as Director/Team Lead, Global Established Products CMC and then becoming the Director of Conformance, Regina embraced a huge change and left Pfizer after 23 years of service.  

Regina was offered a new position with Sanofi U.S., Bridgewater, New Jersey, which would return her to her pharmaceutical Quality roots while leveraging her RCMC experience as a Senior Director, Regulatory Compliance and RCMC.  Shortly after her arrival, she was offered a leader of leaders position, where she is now the Head, Quality Systems and Operations for North America Quality in Bridgewater. She collaborates effectively with her staff of five leads within a pillar of twenty-three members to enable strategies, processes and compliance activities for Quality Document Management, Deviation/CAPA Management, Quality Agreements, Quality Systems Management, Computer System Validation, Quality Labeling Review, Cold Chain Hand Sampling, and External Agency Inspection Management Operations.  She is excited by her new role and feels she is once again being challenged to hone her leadership skills and intellectual curiosity…skills developed in the classrooms of 2474 Ocean Avenue.

Regina lives in Florham Park, New Jersey with her husband Stephen and her three year old twin boys, Michael Andrew and Joseph Alexander who bring her great joy and pride.  She is always striving to find the correct work/life balance as she thrives in her new position, as being present for her growing family is a priority.  

 

Reflecting on her past, Regina remembers fondly the encouragement and guidance she received at St. Edmund – guidance that holds true for her today as a Catholic mother, wife, and professional. Of particular importance were the lines from a song sung by Dan Fogelberg and shared by Mr. Ray Malafronte (talented vocalist, guitarist and teacher) to his students during an assembly.  It truly embodies life during high school and served as words of wisdom to guide her and her classmates along the road of life which lay ahead:

 

“Joy at the start, fear in the journey
Joy in the coming home.
A part of the heart gets lost in the learning
Somewhere along the road.

Along the road your path may wander
A pilgrim’s path may fail.
Absence makes the heart grow fonder
Darkness obscures the trail.

Along the road your steps may stumble,
Your thoughts may start to stray.
But through it all a heart held humble,
Level and lights your way.”

Congratulations Regina on your remarkable career and blessed life.  You make St. Edmund proud!