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In today's episode I was joined by James Myers, VP Quality at Spyre Therapeutics.
I wanted to speak with James about his journey, starting in GCP focussed roles and learn how he transitioned into all encompassing GxP position. As a result James has gained exposure across GCP and GMP and developed himself as a true GxP quality professional.
We discuss the following:
Transitioning from GCP to GMP.Industry Trends.Gaining GMP Experience.Advancing to VP from director.Building a Team and Pilot Plant.Collaboration with Stakeholders.Gaining Organizational Buy-In.Importance of Listening.Strategic Thinking.'Jim' is a great leader and most importantly a genuinely nice human being that has impacted people throughout his career in pharma and biotech. He is a credit to the industry and I'm sure his journey will inspire others to follow in his footsteps!
Thank you Jim for sharing your journey with us!
Hope everyone enjoys the show.
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Today I'm joined by Kelly O'Hare, current Vice President, Head of Quality at enGene, an innovative biotech developing a very exciting non-viral gene therapy focussed on bladder cancer.
Kelly shares her journey in quality, discussing her transition from a technical writer to a quality leader. We talk about the importance of quality leaders being able to articulate the value of quality to their organizations. Her insights provide valuable lessons for aspiring quality professionals and leaders.
Takeaways
Kelly's journey into quality began unexpectedly from a background in broadcast journalism.Mentorship played a crucial role in shaping her leadership philosophy.Building confidence in decision-making is essential for quality leaders.Quality should be defined in terms of efficiency and safety.User feedback is vital for successful quality system implementation.Quality management systems should be tailored to the organization's needs.Evolving perceptions of quality have led to greater appreciation from leadership.Inspiring passion for quality involves recognizing individual interests.Legacy is defined by the success of those you mentor and support.Future quality leaders should be confident yet flexible in their decision-making.Chapters
00:00 Introduction to Quality and Career Journey02:55 Transitioning from Science to Quality Leadership06:03 Building Confidence in Quality Decisions08:52 Defining and Articulating Quality11:59 The Importance of Quality Management Systems14:58 User Feedback and Quality System Implementation17:59 Evolving Perceptions of Quality in Organizations20:55 Inspiring Passion for Quality in Teams23:50 Legacy and Mentorship in Quality Leadership27:02 Final Thoughts and Advice for Future LeadersThis is a great conversation about the significance of defining and articulating quality to your organisation and the benefits this brings.
Thank you Kelly for joining us on the show!
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In today's episode I was joined by Markus Gruell, SVP Quality at Autolus Therapeutics, a late stage clinical development CAR-T cell therapy company headquartered in the UK.
Marcus, shares his journey in the industry and his role as VP of Quality at Autolus. We talk about his transition into the cell and gene therapy field and the challenges and opportunities it presents and move into his experience at Autolus, where he started as an associate director and worked his way up to SVP of Quality. Markus discusses the challenges faced by Autolus in their journey from a start-up to a commercial cell therapy company, the impact of COVID-19 and Brexit on their operations, as well a the transition from a paper-based QMS to an electronic QMS (EQMS) and the importance of having flexible systems.
Transitioning into the cell and gene therapy field requires a steep learning curveThe need for having the ability to work in a fast-paced, evolving environment.The importance of flexibility, adaptability, and collaboration The transition from a paper-based QMS to an EQMS The impact of COVID-19 and Brexit posed challenges for AutolusHow patient impact is the driving force for AutolusHow they strive to provide the best safety and efficacy dataEssential qualities for quality leadersChapters
00:00: Introduction and Overview05:04: Getting into Science and Quality Role09:06: Differences in Quality Practices Between Countries13:34: Transitioning into the Cell and Gene Therapy Field19:25: Implementing Quality Systems at Autolus23:26: Transitioning to an Electronic QMS26:38: Challenges of COVID-19 and Brexit30:43: Patient Impact in Cancer Treatment34:35: Preparing for Pivotal Trials and Commercialization37:28: Looking Ahead: Excitement for Commercialization39:14: Values to Live and Die By41:50: Leaving a Legacy44:05: Advice for Future Quality LeadersThank you Markus for sharing your incredible journey and excited to see you and your teams work come to fruition.
I hope you enjoy the show!
Markus Gruell | LinkedIn
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Today I spoke with Sonia Razzetti, SVP of Quality at Disc Medicine, a clinical stage biotech focussed on developing therapies in the haematology space. Sonia shares her journey in quality and discusses the challenges she faced, including finding her voice in leadership meetings and aligning quality objectives with business priorities. Sonia is really open about the failures she has had to overcome which have helped her develop her career and others.
Takeaways
Finding your voice in leadership meetings Aligning quality objectives with business priorities are common challenges.The most rewarding aspects of working in quality.The value of listening more and speaking less for quality leaderThe importance of diverse perspectives and better decision-making.Chapters
00:00 Introduction and Background03:38 Building a Late Phase/Commercial Ready Quality Management System06:32 Transitioning from Big Pharma to Start-ups10:44 Key Challenges Faced in Career Development15:26 Finding Your Voice and Building Confidence in Leadership20:37 Aligning Quality Objectives with Business Priorities23:06 Shaping Leadership Approach and Mentoring Others24:55 Evolution of Quality as a Profession26:52 Pride in Career Achievements and Future Excitement32:36 Advice for Aspiring Quality LeadersHuge thank you to Sonia for coming on the show and being very open about the challenges she faced in her early career and how she managed to overcome these.
Hope you enjoy the show!
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We are back for Season Two of Lets Talk Quality!
This week, I had the pleasure of speaking with Irving Ford, VP of Quality at Adaptimmune Therapeutics.
Irving has been through the commercialisation of four cell therapy products, most recently leading Adaptimmune through the BLA and FDA approval of their engineered T cell for solid tumour, Tecelra.
Irving talks about his journey from starting out his career as a Microbiologist before making his transition into the pharmaceutical industry. He started in a generics company which exposed him to a variety of product types. He worked his way up into leadership positions, across multiple different aspects of quality, to get to where he is now.
Takeaways
The benefit of working in multiple aspects of quality in your early careerDeveloping trust and building leadership capabilitiesDeveloping different generations of people Putting yourself out of your comfort zone in your careerKey ingredients for moving from clinical to commercial operations in cell therapyUnlearning everything you've learnt when working in cell therapyTraining for mindset and continuous developmentManaging stress, workload and your emotionsIrving's values, views on legacy, inspiration, and advice for future leaders!Chapters
00:00 Introduction and Overview of Irving Ford03:00 Transitioning from Clinical to Commercial Operations11:33 Building Strong Relationships and Creating a Positive Work Culture19:24 Challenges and Real-Time Decision Making in Cell Therapy25:30 Personal Values and Leaving a Legacy32:18 Advice for Future Quality LeadersHuge thank you to Irving for giving us his time!
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Joe Franchetti, President of the Society of Quality Assurance (SQA), shares his vision for the SQA and the wider quality assurance industry, emphasizing the importance of collaboration and expanding relationships with international quality colleagues and regulators. Joe highlights the need to attract and educate younger professionals about the field of quality assurance. He discusses the role of technology, including AI and blockchain, the challenges and opportunities they present, as well as offering advice for future quality assurance professionals.
01:25 - Election as President of SQA05:09 - Vision for SQA and the Quality Assurance Industry07:27 - Promoting Quality Assurance as a Career10:09 - Challenges in Attracting Young Professionals to Quality Assurance13:39 - The Role of Technology in Quality Assurance27:26 - Advice for Future Quality Assurance Professionals29:04 - Joe's Inspiration and Motivation31:02 - Information about SQA and its BenefitsIt was a privilege to be joined by Joe and hear him discuss his vision for the SQA, the wider industry, the role that technology will play, and what benefits the SQA can offer to future and existing members.
Thanks for listening, I hope you enjoy the show!
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This is very special episode. I was joined by Laurie Adami, a financial services exec who was forced to give up her career after a cancer diagnosis in 2006.
After a 12 year battle fighting follicular non-Hodgkin lymphoma, and six lines of therapy, Laurie received a call from her oncologist, informing her about a new therapy called CAR-T, that was being developed by Kite Pharma.
They were opening a clinical trial at UCLA with five patients. Laurie was to be patient number one. One month after her CAR-T treatment, Laurie was in complete remission.
Laurie is now focused on patient advocacy, volunteering and fundraising for cancer research, especially CAR-T immunotherapy.
I wanted to speak with Laurie, to talk about her fight against follicular non-Hodgkin lymphoma, how she learnt about a new game-changing therapy called CAR-T, and some key issues around access to patients, safety concerns raised by the FDA, bridging the gap between industry and patients, and what she is doing now to raise awareness of the benefits and potential of CAR-T. We discuss the following:
[2:40] Laurie's Diagnosis, Initial Treatment and Challenges[5:00] 12 Year Cycle of Six Lines of Therapy and Relapse [10:55] Hearing the Story of Emily Whitehead and CAR-T in 2012[14:22] Starting Sixth Line of Therapy in 2016 [14:57] Receiving a call about a CAR-T Trial in Spring, 2018[18:55] Going Through CAR-T Cell Therapy[21:32] Complete Remission[24:18] Becoming a Patient Advocate Volunteer[26:41] Patient Access and Challenges[35:41] Laurie's Response to the FDA Safety Advisory on CAR-T [41:30] Bridging the Gap Between Industry and Patients[46:16] The Potential and Future of CAR-T Therapy[51:34] Living Life to the Full[58:41] Meeting the People that Saved Her LifeI really hope people enjoy listening to Laurie's story and that it gives hope to anyone affected by Cancer, and raises awareness of the potential for CAR-T Cell Therapy to save more lives.
There are a number of challenges that Laurie is on a mission to tackle, and I would urge people to listen to this episode to learn more about how we can bridge the gap between the industry and patients, and get safter, faster and more affordable access of these therapies to more patients like Laurie.
Thank you Laurie for sharing your story with us!
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In this conversation, Kimberly Wallbank, a quality systems consultant in the pharma & biotech industry, shares her insights and experiences in the world of contracting. She discusses the changes in the contracting market, the types of projects she takes on, and the shift towards remote and on-site work. Kimberly also provides advice on building a network and finding contracts, including the importance of volunteering and referrals. She emphasizes the need for flexibility, problem-solving skills, and a strong support system when starting out in contracting.
Kimberly's Background and Consulting WorkReasons for Getting into ContractingChanges in the Contracting WorldTypes of Projects and Team SizesShifts in Remote and On-Site WorkBuilding a Network and Finding ContractsVolunteering and ReferralsDealing with Slowdowns in the MarketSkills Needed for ConsultingMotivation and Enjoyment as a ConsultantAdvice for Starting Out in ContractingThis is a conversation which is worth listening for anyone considering become a contractor. The contracting market has seen changes, with more consultants entering the market and building a network and proactively finding contracts can be a challenge without the right support systems. Kimberly shares how flexibility, problem-solving skills, and the ability to adapt to different business models are important for success as a consultant.
Hope you enjoy the show!
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This week I speak with Stan Russell, who explains how quality leaders can create a function that adds true value to an organisation.
Stan provides practical advice for leaders to change perceptions and measure the strength of a quality culture. He also shares his leadership style and the importance of storytelling and analogies in articulating quality to the organisation, which can result in a function that is seen as truly valuable. We discuss the following:
What is a 'Quality Culture' and why is it important?Evolution of the perception of qualityHow to measure the strength of a quality culturePractical steps for changing perceptions Utilizing management review to enhance your value How to facilitate team developmentStan's leadership style and analogies he has used to communicateAdvice for future quality leadersThe 'one' soft-skill that Stan would advise leaders to developThis is a fascinating insight into how quality leaders can ensure they are creating a function that puts people and the patient first, whilst enhancing the value and perception of the quality function within their organisation.
Stan is a true leader with an exceptional track record of quality leadership in enterprise and start-up organisations. A huge thank you for coming on the show.
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This week I was joined by Vaishali Shukla, VP of Global Quality Manufacturing at Kite Pharma.
"Act locally but think globally”. This is the mindset that Vaishali has helped instil in her role to help harmonize processes, engage the global network, and create a 'one team' quality approach.
Vaishali talks us through her journey in quality and some of the challenges of leading a global quality operation of 500+ people, and the key aspects which have helped her to get to where she is now. We discuss the below points:
The challenges of managing a global quality operation.Navigating the pandemic and transitioning into a remote world.Managing people in time-zones across the US, Europe, and Asia.Staying relevant with guidelines across different jurisdictions.Balancing compliance and innovation in the cell therapy industry.How to manage M&A and the complex transition that takes place. The evolution of guidelines and technology over the past two decades.How to stay relevant in a constantly evolving landscape.The skills Vaishali has developed to progress to where she is now.Vaishali's outlook on leadership, and within the ATMP space.Whether you want to work in a global operation or small biotech, this is a must listen for any current or aspiring quality leader. So many great insights into the mindset of a highly successful quality leader and some key traits to help accelerate your own leadership career.
I hope you enjoy the show!
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As a biotech professional, how do you know that the questions you ask 'experts' are accurate?
Is the answer based on explicit regulations? Or is it based on personal opinion, which has been formed by historical organisational practise?
In this episode, Greg Furrow, Chief Quality Officer of Mustang Bio, discusses his mission to raise awareness around the importance of industry 'experts' providing accurate and evidence-based information, rather than relying solely on personal experience or company practice.
As a recognised 'expert' himself, Greg talks about organisations and individuals giving disclaimers about their opinions. He encourages both experts and learners to prioritize understanding compliance and to seek the facts rather than blindly trusting opinions. We discuss the following:
The Importance of Understanding ComplianceThe Risk of Mistakes and MisinformationClear Regulations in the Biotech IndustryAnswering Compliance Questions in ATMP'sThe Goal of Understanding ComplianceObligations of Leaders in Answering QuestionsAdvice for Future Quality Assurance ProfessionalsWhat Inspires Greg in his Career.Huge thanks to Greg for sharing his views and raising awareness around this important matter. Greg is on a mission to move away from giving subjective personal opinions based on organisational practises - towards a compliance framework anchored in explicit regulations and guidance documents.
Enjoy the show!
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This is a story about the journey of commercialization for BMS' first cell therapies approved for the treatment of blood cancer.
Jason 'Jake' Treese, played a critical role in the development, approval and commercialization of Abecma and Breyanzi; two cell therapies which have now treated 4,700 patients in clinical and commercial settings - patients that are often on their last line of treatment, and last hope of a successful treatment.
We discuss leading the quality function in CAR-T cell therapy, the challenges faced in gaining approval for these therapies, the background of CAR-T cell therapy, the importance of building a strong team, the setbacks encountered during the approval process, and the motivation and inspiration behind the work.
Understanding CAR-T Cell TherapyLeading the Quality Function in CAR-T Cell TherapyBuilding the Team and Planning for SuccessChallenges and Setbacks in the Approval ProcessMaintaining Motivation and MissionThe Approval and ReflectionsAdvice for Quality Leaders in Cell TherapyConsiderations for the IndustryReflections on the Impact of Cell TherapyIt's an incredible, emotional, and highly insightful story. For anyone that is leading an organisation through clinical development, particularly within cell therapy, this is a must listen!
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This week on the podcast I speak with Emily English, VP of Quality at Cartesian Therapeutics.
Cartesian is a clinical-stage biopharmaceutical company developing RNA cell therapies designed to benefit the wide range of patients with cancer, autoimmune diseases, and respiratory diseases. We discussed RNA cell therapy and how Cartesian are bringing forward their mission of developing safer cell therapies for patients with autoimmune diseases. We talk about the following in detail:
The work Cartesian are doing in RNA cell therapy and why it is exciting for patients.How early data suggests that Cartesian's lead programme can provide durable therapeutic benefit to patients with autoimmune diseases.Why Cartesian brought manufacturing in-house, the implications and the benefits of internal manufacturing.The transition in thinking and managing for risk and potential downtimes in the future versus planning for success.The challenges of bringing autologous cell therapies to patients at scale.Creating scalable processes for commercialisation, ensuring sustainability, and streamlining quality processes.At which stage in clinical development should organisations be thinking about creating scalable processes.How Cartesian are changing the way traditional cell therapies are developed and the implications of these changes.Emily’s values, her outlook on leadership, and what inspires her.It was a pleasure to speak with Emily. It’s hugely exciting to see the incredibly innovative work that her and the team at Cartesian are doing to help patients suffering from autoimmune diseases. I’m looking forward to seeing the progress that Emily and her team make in bringing these therapies closer to the patients as they scale in a commercial setting.
We will definitely have another conversation in 12 months time to see how things are progressing at Cartesian!
I hope you enjoy the show!
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The volume of data integrity violations cited in FDA warning letters has risen alarmingly over the last decade.
Several examples of poor data integrity practises have demonstrated the consequences it can have on a biotech's future, particularly when is occurs at an early stage of development.
In episode 11 of Let's Talk Quality, I was joined by Brian Furmanski, Chief Regulatory Officer for Kriya Therapeutics.
Brian has a large remit, covering regulatory, quality and clinical, and is passionate about all things data. He speaks about his background with the FDA, his journey to Kriya, and how he is implementing a culture of data integrity in his current role. We discuss the following:
The importance of data integrity in pharma and biotech.What does good data integrity look like? How Brian drives a culture of data integrity in his current role.Data integrity gone wrong - real life examples.The consequences of poor data integrity practises. When biotech's should be thinking about developing more robust quality systems.How to start building better data integrity practises into your business.The challenges of overseeing multiple functions in a start-up biotech.Huge thanks to Brian for joining us on the show and sharing some best practises for implementing great data integrity practises. For a biotech leader, especially if you're in preclinical studies, ensuring you are implementing and embedding a culture that drives data integrity excellence is paramount to your future success.
I hope you enjoy the show!
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This week I spoke with Jacob Patterson, VP quality for a clinical stage biotech in Rhode Island.
Jacob, by his own admission, has had to continuously adapt, learn and be flexible in his approach to quality leadership. We had a great conversation about what skills the quality industry will demand in the next 10-20 years. We spoke about what Jacob thinks quality professionals should be doing now, from both a technical skills and a leadership perspective to help grow their career, develop succession, and become a great quality assurance leader in the future. We covered the below in detail:
Working in a smaller biotech compared to larger organizationsWhat makes a high performing quality function today?How times have changed and why quality isn't known as the police any moreHow speed, agility and data analysis are the skills quality professionals need to be learning nowData integrity and analysis, and it's significanceHow the industry can develop more quality leaders Managing people and how to deal with difficult employeesDefining the ROI of quality and getting quality a better seat at the tableWhat to look for in your people when building a teamThank you to Jacob for giving us his insights into the world of quality assurance and it's future. Jacob is honest about his assessment of the current landscape of quality assurance and what he believes, the skills that QA professionals should be working on now, to build a successful career for the future.
Hope you enjoy the show!
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This week, we spoke with Brian Nunnally, and discussed some of the challenges that Brian faced throughout his journey to where he is now, Global Head of QC at CSL.
Brian is hugely passionate and is driven by being a part of and leading the best quality control function in the world.
What I liked about this conversation was Brian's honest assessment of his struggles and frustrations that many people will be going through right now. We spoke about why lateral moves and working in different functions might sometimes not be a bad thing for your longer term career prospects. We also delved into what a great QC team looks like - the metrics that Brian holds his leaders accountable to and the key pillars to building a global QC function.
We cover the below in detail:
How having different experiences in QC, regulatory, technical has shaped Brian's careerHow a lateral move can benefit you in the long termThe importance of multiple mentors in the early and middle phases of your careerHow to build resilience in your career and advice on identifying your 'North-Star' The three key things which make a world-class QC team The metrics that Brian and his team monitor Brian's leadership style and how he develops his peopleWhat makes a great QC leaderBrian was a pleasure to speak with. His journey to now being part of an organisation that is developing vaccines that saves lives is inspiring. This is a must listen for anyone who is leading a QC team or an aspiring QC leader. In addition, for anyone who is feeling frustrated with their career progression, Brian provides some great advice for getting through the frustrating times, really understanding what you want to achieve and where you want to go.
Hope you enjoy the show!
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This week I was joined by Peggy Owens, Head of Quality at Kincell Bio, a CDMO operating in early phase cell therapy.
Peggy has an extensive background in cell therapy, having worked on both the CDMO and sponsor side. We had a great discussion about the challenges of building and leading a quality function in an area of medicine which is constantly evolving. We discussed the following:
The challenges of overseeing quality at a CDMO in the CGT spaceHow to develop a team that can operate in uncertain environments The importance of quality working 'on the floor' alongside manufacturingHow to develop processes and procedures to upskill your teamHow to go about getting 'the right people in the room'Examples where things have gone wrong and how Peggy handled thisThe differences between working in a CDMO v sponsor sideAdvice for collaboration between CDMO's and the sponsor companyPeggy's attitude towards quality, the industry, and the patient is inspiring. One of the goals of this is show is to inspire future quality and biotech leaders. Peggy's purpose and motivation shines through in this episode, and she provides an excellent insight into how to develop and upskill quality professionals to help them operate in the grey area of cell therapy, particularly in the fast-paced CDMO world.
Thank you to Peggy for coming on the show and providing such great insights.
I hope you enjoy the show!
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On this weeks show, I speak with John McKay, a well respected, well loved and highly seasoned quality assurance leader in pharma and biotech across clinical development and commercial manufacturing.
John breaks down four key pillars that he believes are critical for achieving quality assurance excellence and developing world-class quality functions. We discuss the following:
What it takes to be a great quality assurance leaderJohn's experience of being trained by Dr W. Edwards DemingThe importance of senior leadership teams commitment to qualityHow John uses his sporting experience to help coach his team membersThe importance of team-work and collaboration across the businessHow to excel in global know-how through knowledge managementJohn's advice for future quality assurance leadersThank you to John for giving us some key insights into some of the key factors that contribute to becoming a world-class quality leader. It's always a pleasure to speak with John. His positivity and energy is infectious and you can see how he's forged such a successful career in quality. He is a great mentor for anyone looking to develop their leadership career.
I hope you enjoy the show!
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Welcome to episode 6 of Let's Talk Quality.
I was joined by Greg Whitehead. Greg is Head of Quality at Editas Medicine and has been working in biotech for 30 years, with a particular focus on cell and gene therapy.
Greg has a vision to leave the quality assurance industry in a better place than when he started in the industry. We spoke about why this is important to him and what he is doing to help bring this vision to life. We spoke about the following:
How not many people set out to have a career in quality assurance, and why this isa benefit to the industry.As Greg grew in his career, why he began thinking about what he's leaving behind in the QA industry. How to relationships with regulatory bodies and health authorities have evolved over the years.Greg's advice for inexperienced QA professional in how to work well with the FDA.What makes a truly talented quality assurance leader in biotech.Embedding quality as a culture and mindset in the industry.Finding the balance when building quality functions.The legacy Greg wants to leave behind him.Greg has a huge passion for the quality assurance industry and developing leaders that can help move the industry forward. He has achieved a lot in his career so far, and will continue to add value to the wider industry. I'm looking forward to seeing Greg and the team at Editas develop their gene therapies as they move closer to bringing them to commercial use.
Greg was an inspiration to speak with, and I'd urge any QA professional looking to develop their leadership career to listen and reach out to Greg!
I hope you enjoy the show!
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There are 6 female CEO's of biotech companies with a market cap of over $5bn.
In this episode, I was lucky to speak with Christy, who is an incredible advocate for females in quality and the wider biotech industry. Christy has an incredible passion for helping other females leaders overcome some of the struggles that she has faced in her career. Christy chairs a women in quality group for ASQ where men and woman come together to break down the barriers and challenges for woman in the workplace and what both men and woman can do to help overcome these challenges.
Why Christy is such a strong advocate for females in quality assuranceSome of the key obstacles female leaders typically face in biotech The role that mentors can play in personal and career developmentImportance of finding a great mentor who is in line with your values Specific aspects females can struggle with in negotiating Building credibility and being seen as a valued business partnerThe benefit of really getting to know people in your company and network The 'Circle Philosophy' - what this is and how it can influence your life How being self-aware in minimising unconscious bias in the work-placeHow to find a good work-life integration The importance of aligning your company with the culture that you want to createThe advice Christy would give to her younger self Christy's vision for woman in quality assuranceThis is a conversation that should consistently be happening. For the industry to continue to develop and grow, we need more female leaders, and we need more people like Christy helping those who may be facing the same challenges she has faced in her career.
Christy gives some really practical advice to females at any level who are looking to build their personal and career development. Whether you’re a male or female, this episode will give anyone in the work-place some great insights into the challenges females face, and what everyone can be doing to on how to help create a better culture, improve employee retention and progress the industry forward.
I hope you enjoy the show!
- Visa fler
