Rx Group

How to Build a QC Leadership Career in Cell Therapy 🚀 Scaling a QC team for commercialization in cell and gene therapy isn’t just about adding more resources, it’s about building the right structure, processes, and leadership mindset to handle the pressure. In this weeks newsletter, we break down some of the insights from our latest podcast episode featuring Andrea Sutter Karpinecz: 🔹 How QC leaders can prepare for commercialization 🔹 The skills that separate great QC leaders from the rest 🔹 Why hiring for mindset is just as critical as technical ability 🔹 What’s next for QC in the future of cell therapy If you're a QC professional looking to grow your career, or a QC leader preparing for commercialization, check it out!

🚀 Can introverts thrive in leadership? Absolutely. Some of the most effective Quality leaders we work with aren’t the loudest in the room. They lead through deep thinking, strong listening skills, and a measured approach to decision-making. Yet many introverts still question whether they’re ‘leadership material.’ In our latest newsletter, we explore how introverts can build confidence, influence effectively, and step into leadership without changing who they are. Featuring insights from Shane Ernst, VP of Quality at Empower Pharmacy, we break down what it really takes to lead with impact, regardless of personality type.

Would you move to a new country with no network, no guarantees - just a dream and two suitcases? That’s exactly what Katarina Bartle did. She left Slovakia, where she had built a strong academic foundation, moved to Germany for her PhD, and then took a huge risk, relocating to the U.S. for what was meant to be a short postdoc. 27 years later, she’s still here - now a biotech quality leader who has shaped global teams and helped redefine how companies approach quality. In today’s episode of Let's Talk Quality: The Podcast🎙️, Katarina shares: ✅ The challenges of moving to a new country and building a career from scratch. ✅ How she transitioned from scientist to compliance and quality leader. ✅ The importance of having a strong voice in leadership discussions. ✅ Why quality leaders need to think like business leaders, not just auditors. ✅ Her biggest leadership lessons and career advice for aspiring VPs. This one is packed with career insights, resilience, and real leadership lessons—don’t miss it. 🎙️ Live today at 12pm EST / 5pm GMT on Hemish Ilangaratne LinkedIn, Apple, and Spotify!

Biana Torres speaks with Hemish Ilangaratne on the latest episode of Let's Talk Quality: The Podcast🎙️ about her tactics of believing in her team and how to lead them. 🎧 Listen to the full episode here: Spotify: https://lnkd.in/eJ_aEf6v Apple Podcasts: https://lnkd.in/e7dPewHJ #QualityAssurance #LetsTalkQuality #QualityLeadership #Pharma #Biotech

🔬 Breaking Into Cell & Gene Therapy: How to Overcome the Experience Barrier Many quality professionals want to work in cell & gene therapy, but there’s a common challenge - companies often require CGT-specific experience, making it difficult for those coming from small molecule, biologics, or MedTech to make the leap. In the latest episode of Let’s Talk Quality, we sit down with Biana Torres, Senior Director of Quality Assurance at Encoded Therapeutics, who faced this exact challenge. Despite years of experience in quality leadership, she was told no multiple times when trying to enter the CGT space. Recruiters wouldn’t put her forward. Hiring managers dismissed her. So how did she break through? 🧬 How to position transferable skills for a CGT role 🧬 The mindset shift needed for success in advanced therapies 🧬 Why some hiring managers prioritize attitude over experience 🧬 The biggest challenges CGT companies face in quality today Biana’s journey proves that breaking into cell & gene therapy is possible - if you take the right approach. 🎧 Listen to the full episode here: Spotify: https://lnkd.in/eJ_aEf6v Apple Podcasts: https://lnkd.in/e7dPewHJ

Do great leaders have to be extroverts? Some of the most effective biotech leaders we’ve worked with at Rx Group are introverts. They don’t need to be the loudest in the room. Instead, they lead through deep thinking, strong listening skills, and a measured approach to decision-making. ✅ They influence through trust and credibility, not volume. ✅ They drive results by creating high-performing teams. ✅ They communicate with clarity and intent, ensuring their voice matters. Whether introverted or extroverted, the best leaders adapt, influence, and create impact. For anyone that resonates with this, listen to Shane Ernst's journey in S2 E18 of Let's Talk Quality: The Podcast🎙️ - episode link in the comments. ⬇️

Thriving as an Introverted Quality leader! Listen back to our latest episode of Let's Talk Quality: The Podcast🎙️ with Shane Ernst, as Hemish Ilangaratne talks with him about: ✅ How Shane’s personal story influenced his decision to enter the pharmaceutical industry. ✅ Overcoming self-doubt as an introvert to become a quality leader. ✅ The moment that changed his career - being thrown into cleaning validation early on. ✅ Why quality leaders need to understand finance, R&D, and supply chain. ✅ Turning around troubled sites - including a 1,300+ complaint backlog and FDA scrutiny. ✅ The importance of building trust with regulators and how to approach FDA interactions. ✅ Adapting leadership styles in a post-COVID world with remote teams. ✅ Key traits of successful quality leaders and the power of mentorship. Listen to the full episode here: https://lnkd.in/emeSYGrc #Let’sTalkQuality #QualityLeadership #Pharma #Biotech #RegulatoryCompliance #CareerGrowth #Mentorship

S2 EP16: John Voss on making practical decisions that put patients first Join Jon & Hemish as they share invaluable insights on: 💡 Moving from compliance to patient-first quality. 💡 Career growth through diverse roles. 💡 Lessons from commercialization milestones. 💡 Balancing innovation with safety. 💡 Using AI to accelerate drug development. 💡 Public speaking to boost career opportunities. Whether you’re a newcomer or a seasoned leader, this episode is packed with wisdom and inspiration for all levels. 🎧 Watch here: https://lnkd.in/eYKsHgFi

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Our final episode of 2024!🎉   Season 2 | Ep 15 - Hanh Nguyen on Imposter Syndrome, Mental Health, and Leading with Authenticity. 🎙️   In our last episode of the year, Hemish is joined by Hanh-Uyen Nguyen, Site Head of Quality at Minaris Regenerative Medicine, a leading CDMO in the cell and gene therapy space.   Hanh’s career started in document control at Amgen, spending over a decade in Big Pharma, before taking a leap into smaller, fast-paced organizations. That move - stepping out of her comfort zone, was a pivotal moment that accelerated her growth and confidence as a leader.   In this episode, Hanh shares:   🔹 How she overcame imposter syndrome and built confidence in her leadership style. 🔹 Why mental health and self-care are crucial for high-performing teams. 🔹 Practical strategies for managing and motivating a new generation of talent. 🔹 The keys to building strong, transparent relationships between sponsors and CDMOs.   Her advice to aspiring quality leaders:   “Trust your experience, prioritize communication, and always lead with sincerity.”   If you’re a quality leader (or aspiring to be one), this episode is packed with practical tips and insights on building high-performing, engaged teams while staying true to yourself. 📽️ Watch live on Hemish's LinkedIn page at 8am PST/11am EST. 🎧 Listen on Apple or Spotify!