Meet Lynne Ensor: Senior Vice President & Head of RCS Global Compliance

"We are in a historic situation and am proud our team has been part of developing solutions to support the global response to COVID."

Please introduce yourself and your role at Parexel.
Hello, my name is Lynne Ensor, and I am a Senior Vice President and the Head of the Regulatory Consulting Services (RCS) Global Compliance team. 

• Can you tell me a little about your background prior to Parexel?
  Prior to joining Parexel, I was employed by the U. S. Food and Drug Administration (FDA) for 21 years and served the federal government in a variety of capacities. My academic training, including earning a Ph.D. in Microbiology, supported the development of my regulatory expertise in sterile product manufacturing and testing, pharmaceutical microbiology, manufacturing facility compliance, and regulatory strategy. While at the FDA, I provided regulatory oversight for new, generic, biologic, and biosimilar drug product quality (CMC) review and facility assessment. My previous professional experience also includes serving as a Clinical Microbiologist at Roche Biomedical Laboratories, a script consultant for the Discovery Channel, and a Post-doctoral Fellow at the University of Maryland at Baltimore’s School of Medicine.

• Can you tell me what a day in your job looks like and what your core responsibilities are?
  The management component of my current role involves providing oversight to the RCS Compliance Team. Our compliance team supports clients in developing products to ensure they meet global regulatory agencies’ expectations, as applicable, and are able to manufacture and distribute medical products in a compliant manner. Additionally, I am a member of the Regulatory & Access Senior Leadership Team. This part of my position’s role allows me to be involved with the development and execution of global regulatory business strategy, with a focus on innovative methodologies and services, to expand our company’s global regulatory and compliance consulting services.
  
  In addition to managerial responsibilities, my RCS work involves providing strategic regulatory lifecycle support and supply chain integrity for products and clients using my technical and regulatory expertise. This may include providing strategic regulatory submission support, commercial manufacturing planning, and remediation expertise for various regulatory submissions (e.g., INDs, NDAs, BLAs, ANDAs, and DMFs). Additionally, my role may include providing support for demonstrating compliance with regulatory expectations (such as current good manufacturing practices), risk assessment and mitigation, data integrity, developing quality management systems, and remediation strategies for manufacturing facilities (e.g., to remediate regulatory consent decrees, warning letters, 483 observations, and drug shortages). Lastly, I am involved with developing thought leadership materials to align with current regulatory expectations and industry needs.
  
  
• When did you join Parexel and why did you choose Parexel above our competitors?
  I joined Parexel in 2019, immediately after being a regulator at the U.S. FDA. A significant reason I join Parexel was because of the company’s exceptional reputation with regulators. As a former regulator, when we (regulators) were aware that a sponsor was working with Parexel to remediate challenging situations, identified by regulators either during their development or commercial manufacture and distribution, there was a great deal of confidence that the sponsors had the support to appropriately address and remediate the situation with a quality solution. This typically resulted in a positive sponsor engagement and outcome with regulators. I wanted to be part of an organization with a strong reputation for quality performance.
  
  My regulatory background is in CMC, compliance, and biopharmaceutical quality. Continuing to support the development of quality products and manufacturing processes as a consultant working for a well-respected company, such as Parexel, was very important to me. As a regulator, I was highly involved in addressing and working with sponsors to remediate quality issues, ensuring products were meeting (at a) minimum quality regulatory expectations, and attempting to prevent national drug shortages. These issues were sometimes acutely focused in certain global regions. I enjoy working for Parexel since it is an international company. This allows me the ability to support promoting quality in some regions where the FDA had concerns regarding its consistency and work towards ensuring the global population has access to products of the same quality standards. I am very proud to be on the other side of the table from regulators now, but still working towards the common goal of ensuring patients have access to safe, effective, and quality products.
  
  
• What would you like people to know about your job or department?
  The RCS Compliance team is comprised of amazing, collaborative, and dedicated staff with industry-leading and ex-regulator technical expertise. Our team provides rapid support to clients facing frequently time-sensitive and complex compliance challenges. Their dedication to supporting clients and ensuring patient access to compliant products has been unparalleled. Their dedication has been witnessed throughout the pandemic. Our team was often traveling to support clients on-site to provide comprehensive support when it could not be achieved virtually and was desperately needed to support products being developed and manufactured to globally combat the pandemic.
  
  
• What is it about your position that challenges you most?
  For compliance support, there is often a sense of urgency to address and remediate non-compliant situations clients face, as it may impact patients’ access to products. Therefore, I think the most challenging part of my role is to provide quick responsiveness to clients when they face challenging and time-sensitive regulatory or manufacturing challenges that need immediate remediation.
  
  
• How would you describe what it’s like to work at Parexel?
  I thoroughly enjoy working for Parexel! I like that my position includes individual and teamwork aspects, all of which I perform decentralized. Due to this flexibility, the pandemic minimally impacted my ability to work on group projects or with clients. My position also allows me to use my technical expertise, in a flexible manner, to fit my personal interests while supporting clients in developing and manufacturing critical products for global health. I also learned that I love working for a global company. It provides me with an environment to continually learn more about various regions, people, and regulatory expectations to support global health.
  
  
• What excites you most about the work you do?
  As a manager, I enjoy determining what people’s strengths are and developing teams to function optimally by supplementing individuals’ skill sets on teams and projects. This also provides an opportunity for teams to learn from each other and hopefully continue to develop individually by gaining insights on best practices and applying them. Lastly, I enjoy supporting and watching individuals grow and develop in their desired career paths to find roles that best suit them allowing for optimal professional performance and personal satisfaction
  
  Regarding compliance-specific technical work, I have enjoyed and felt extremely valued during our work with clients and/or products being developed to combat the pandemic. We are in a historic situation and I am proud our team has been part of developing solutions to support the global response to COVID.
  
  
• Can you share with us an example of some of the work that you do, where you have gained a real sense of job satisfaction?
  Our team’s work to support clients and their products to combat the global SARS-CoV-2 pandemic has been extremely satisfying and provides me with a sense of immense pride.
  
  
• How has Parexel supported your career development?
  Parexel has afforded me numerous opportunities to develop my career, even though I have been with the organization for a rather short period. An example of this is my current participation in Parexel’s Women In Leadership (WIL) program. The WIL program had been an amazing experience so far! It has provided me with extensive tools and insights to support my development and optimize my career’s success.
   
• Tell me something most people don’t know about you.
  I recently started playing pickleball and really enjoy it! It is a fun sport with a friendly and welcoming environment. I just returned from my second tournament and earned a silver medal in singles, improving from my first tournament’s bronze medal. I am proud of this accomplishment since I’m not getting any younger 😉 and want to play singles as long as I can as it is my favorite.

• What do you enjoy when you’re not at work?
  Besides spending as much time as possible with my daughters and our dogs, I enjoy playing tennis, pickleball, and any outdoor activity.
  
  Pictured: Lynne and her daughters at a Washing Capitals hockey game

• What is your untrainable superpower?
  Persevering in challenging situations. I’ve had endured unbelievable and unexpected personal challenges. Navigating them and supporting my family during these was a huge challenge, but believe they made me a stronger person for having done so.
  
  Do you want to work with Lynne and her colleagues? Learn more about Regulatory opportunities here. 
  
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