Women in Pharma® Expands Its Global Reach

Inaugural ISPE Women in Pharma® Event Held in India at the 2019 ISPE South Asia Pharmaceutical Manufacturing Conference

The panel consisted of both women and men working for manufacturing companies, service providers, and regulatory agencies, representing different countries and career stages. This diversity of perspectives was evident in an insightful discussion.

The panelists were:

David Churchward

Head of Operations Quality Compliance and External Affairs

AstraZeneca

Ranjana B. Pathak, DHA

Lupin Limited

Richi Sethi

Bioprocess Systems Specialist, Merck Life Science

Merck Life Science

Aditi S. Thakur

Senior Pharmaceutical Quality Assessor

FDA/CDER/OPQ/OPF

Frank Verni

RPh, MPH, Compliance Officer

FDA/CDER/OC/OMQ

Frances Zipp

President/CEO

Lachman Consultant Services

Moderator:

Caroline Rocks

Senior Program Manager

AbbVie, Inc.

Session Proceedings

Zipp opened the session by offering background information about the ISPE Women in Pharma® initiative and details on its various aspects, including Mentor Circles and travel grants. She issued a call to action to the audience to encourage their women colleagues to become part of this initiative.

Pathak shared insights about working in the US and India as a woman leader, including distinctive aspects of her experiences in each country.

Thakur spoke about her own career journey from studying and living in India to moving to the US, and how some aspects were unplanned, such as moving from her initial career as a chemist in research and development to joining the FDA.

Sethi shared the challenges associated with unconscious bias that she experienced at the beginning of her engineering career and asked the audience to be more aware of this issue for women engineers who are just starting out.

Both Pathak and Zipp followed up, emphasizing that although the industry has made tremendous progress in achieving gender diversity since they started their careers 30 years ago, challenges persist. Women in the industry still need encouragement and empowerment.

Churchward shared his perspective on how diversity and culture can impact conduct in compliance or inspection. Teams of empowered and diverse individuals can facilitate critical thinking and reduce bias. This enables robust decision-making based on quantitative risk management to ensure product quality, while also contributing to an “enabling environment” for personal development. Churchward reflected that this approach is also applicable to inspection teams; specifically, the skills and perspectives used to assess compliance will differ as teams operate in different cultural environments.

Verni emphasized that when you limit the degree of diversity in a workplace, you lose an immense untapped pool of talent, skills, and experiences. A diverse workforce increases creativity and productivity. And, “it will reduce fear and grow a strong quality culture that will in turn benefit the company in a multitude of areas. As an added bonus, it will also boost the company’s reputation among a variety of stakeholders.”

Zipp shared her perspective on the unique challenges working parents encounter in a manufacturing environment, and how to overcome them. “These days, work demands more than a 9-to-5 commitment. Therefore, you need backup plans. Ask people for help—needing people does not make you needy! I raised my three children for the most part alone, and I was most grateful for the support of family, friends, and coworkers,” she said. “Also, be realistic and make choices that you can live with—if you want a job that requires you to travel, accept that you will need help with household items and childcare. If you cannot accept that or afford that, find another role.”