2017 ISPE/FDA/PRQI Quality Manufacturing Conference

Women in Pharma 2017: Bringing Education to Gender Parity

There was palpable excitement in the air as conference participants gathered for the Women in Pharma (WIP) breakfast on day 2 of the 2017 ISPE/FDA/PQRI Quality Manufacturing Conference. WIP Chair Fran Zipp, President and CEO, Lachman Consultants and ISPE Board member, welcomed the audience of more than 100 attendees.

“Women in Pharma began as a small idea for the ISPE Annual Meeting last year,” she said. “We wanted to get a group of people together to talk about how do we help women move forward in their career. The response was terrific and so we decided to formalize the group, and here we are.”

Emily Stump, Director of Operations, Pacific Northwest, Commissioning Agents, Inc., introduced the panelists and facilitators: Mihaela Simianu, PhD, Director, Regulatory Compliance, Pharmatech Associates, Inc.; Kellie Schoolar Reynolds, PharmD, Deputy Director, OTS/OCP/DCPIV, US FDA, Center for Drug Evaluation and Research; Tammie Champlin, Senior Director, Quality Engineering, Johnson & Johnson; and Valerie Jensen, Capt., RPh, Associate Director, Drug Shortage Staff, US FDA.

“I am proud to be a part of this accomplished panel and room,” said Stump. She proceeded by asking two of the panel members, Dr. Simianu and Kellie Schoolar Reynolds, to respond to a question, so that audience participants could get to know them. Dr. Simianu was asked which single characteristic she attributes to her current success. “Courage to do things I have never done before is what has helped me most,” she said. “I was always present to grasp an opportunity without fear and without thinking, ‘Am I really qualified to do this?’”

Stump asked Dr. Simianu how she dealt with fear. “You have to acknowledge that fear is always present,” she said. “You need to feel it, and work through it.” She cited mentorship, networking, and support as motivators, and added, “We are always well equipped to manage.”

Stump then asked Schoolar Reynolds to talk about a defining or pivotal moment in her career. Schoolar Reynolds related the story of an interview process for division director at the FDA. “During the final interview, I didn’t sell myself and I didn’t have the courage to talk about my unique skills, and what I could bring to the position,” she said. “I had already decided it was OK to not get the job, because the other person really seemed like the default choice.” When the winning candidate was announced, Schoolar Reynolds found there were women in the office who were disappointed she hadn’t got the position. “I didn’t realize how important it was for other women in the office. I lost an opportunity to be a role model.”

Champlin addressed the important role played by mentors in a person’s career. She shared that one of her mentors was her father, who taught her to “remember the little guy,” words she said are always with her. “I always ask myself how I can support and serve my team.”

“The best mentors are those that get to know you a bit,” she added, “and they don’t always come from places you might imagine.”

Champlin also highlighted the importance of having a sponsor, someone to “speak on your behalf and be your ambassador.”

Stump then asked Captain Jensen what would be the core message she would share with someone developing their career. Her response was to the point: “Take pride in your work and do the best you can, even if you don’t have the job you want to have.” Table discussions on assigned questions followed, after which Zipp asked for volunteers to share their summaries. One table discussed how women could best contribute to the success of developing female leaders. Their conclusion was that getting involved in organizations like ISPE, and networking, is key as is early mentoring in one’s career. Another table, whose topic was overcoming obstacles to success, stated the importance of “getting out of your own way” and “owning your skills, experience, and ambition.”

Zipp then offered closing remarks to the breakfast event.

“It’s time to give back,” she said, “time to bring technical knowledge and leadership skills to all our colleagues,” Zipp told the audience of the profound impact of the words of colleague Mary Oates, PhD, Vice President, EHS and Global Quality Operations, Pfizer, Inc., during the first WIP event at the 2016 ISPE Annual Meeting. “Mary said that when she wanted to move into a role, a new job, she would look around and say to herself: ‘I may not be the most qualified person, but I want it the most’. For her, it is about the passion, and I would like to say that this initiative is about the passion, too.”

She then thanked ISPE CEO and President John Bournas and Board Chair Mike Arnold for their support and for driving the WIP initiative within the organization. Zipp also expressed gratitude to sponsors Johnson & Johnson and Pharmatech. Audience members were encouraged to sign up with the WIP group and to participate in one of four committees: education, collaboration, marketing, and academic.

Watch this space for more insights from the discussions at the WIP breakfast.

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