Vice President, Global Quality Systems and Compliance
You have been an ISPE Member for 30 years! During that time, you have done so much for the Society (thank you!). Currently, you are the Co-Chair of ISPE Women in Pharma® and serve as a Board Member for the ISPE International Board of Directors and the ISPE Foundation Board. You have also worked with and Chaired numerous committees in the past. Can you share some of the highlights of your long-lasting, and very busy, involvement with the Society? What are some of your successes you have experienced while managing these many roles and responsibilities?
My involvement with ISPE evolved as my own career advanced, starting as a young professional interested in learning from and connecting with as many individuals as I possibly could, to where I am today. Through ISPE, I gained the knowledge, experience, and confidence to grow professionally and expand my involvement in multiple ISPE activities, as a presenter, committee member on the North American Regulatory Advisory Committee, the Biotech Conference Program Committee for four years, and as a liaison and speaker for the 2019 ISPE Asia Pacific Pharmaceutical Manufacturing Conference. What I most enjoy is being in a position to give back to the Society through my involvement on the ISPE Membership Development Committee, the ISPE Foundation Board and Development Committee, the Student Hackathons, and of course through Women in Pharma. With every engagement, I meet and connect with new people across the globe, and I get the chance to work with some amazingly committed and talented ISPE staff and fellow volunteers. Reflecting on it all, while there are many highlights, I can say that I am the most proud of the growth we have had with Women in Pharma, and how we have come together as a global coalition of women supporting each other across geographic, organizational, and cultural boundaries.
You have been a wonderful mentor to ISPE Student and Emerging Leader Members. What inspires you to do this, and how does working with and on behalf of these younger people fit into your very obvious desire to “give back”?
I learned so much from leaders before me that I want to be in a position to do the same and support the future of our industry. I am so inspired by the energy, commitment, and pure talent of so many of these younger people that it is easy to find time to engage. I had the honor of serving as a judge for the last two (virtual) ISPE Student & Recent Graduate Hackathons, where the approaches to address complex problems were so well researched and presented. I am also energized when I mentor women and students, and to date, I have maintained several of those mentoring relationships, some of which have become personal friends. I learn so much from these younger people that I look forward to continuing to give back. I am excited for next opportunity to engage with students and emerging leaders. Along with my ISPE Women in Pharma® co-chair, I will be speaking at the Northeastern University / Boston Area Chapter webinar on 8 April 2021, on a Women in Pharma Panel on the topic of overcoming discrimination in the workplace. The event is hosted by the ISPE Student Chapter at Northeastern University, and all ISPE Student Chapter Members, Student Members, and Emerging Leaders in ISPE have been invited.
You are the Founder, President and CEO of Arencibia Compliance and Consulting, and are currently bringing your experience in support of one of the Covid-19 Vaccine manufacturers. Prior to launching your organization, you spent more than 20 years with Novartis. Can you share some insights on how women in business, specifically pharma, can make a difference?
As women, we have an opportunity to change the dialogue about what leadership looks and sounds like, we can bring empathy to the workplace, and we can achieve personal and collective success by supporting the growth and development of other women. There are so many studies that support that greater diversity brings about greater innovation and engagement. Therefore, it is clear that women have a role to play in paving the way for current and future generations of women to succeed in roles traditionally reserved exclusively for men. One needs only to look at the current crisis, and see the role that female scientists/leaders, such as Dr. Ozlem Tureci, co-founder of BioNTech, or Katalin Karinko, one the vaccine developers, played in bringing forward preventative vaccines or therapeutics. But to tap into that potential, women have to help both men and women overcome obstacles, some of which, at least in the case of some women, are self-imposed. Women can change that perception by instilling confidence among our female associates, mentoring younger leaders, remaining grounded and authentic to ourselves, and never apologizing for committing to the things that matter.
You are a successful entrepreneur with four young adult children and an extremely busy job (that has required relocation during the past several months) – and you are currently attending a law program - but somehow you manage to spend a substantial amount of time on ISPE initiatives. How do you find the energy and time to do so much?
I don't find that I need to make time to be a part of ISPE. It just happens, and it fits within my goals. I love what I do, and I am lucky that I can focus on those things that matter most to me. These engagements energize me, it is not the other way around. As a life learner I draw from all of my ISPE, business and personal experiences to be a better person. I find that as long as I am learning something every day, I am happy and motivated to do more.
Anything else you’d like to share?
I am looking forward to the future. I am so proud of what our industry has accomplished, and the resources collectively brought to bear to address this crisis. I am humbled daily by working with incredibly talented, committed, and diverse professionals across all groups. I can't wait to get back to a face-to-face meeting or see a live performance at a theater!
As the world’s second largest market for pharmaceuticals and accounting for 20% of global medical device sales with double digit annual growth, the Chinese market is poised to have a significant impact on expanding patient access to innovative therapies and combination products (CPs). 1
1Chinese Medical Device Industry: How to thrive in an increasingly competitive market?
Digital transformation is the novel use of digital technology, including instrumentation and control systems, to solve traditional problems in a transformative manner. These digital solutions enable inherently new types of innovation and creativity, rather than simply enhancing, and supporting traditional methods.