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Quality Culture

Driving Transformation in Quality to Meet the Needs of Our Customers
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Driving Transformation in Quality to Meet the Needs of Our Customers

A relentless visionary, Robin Kumoluyi consistently moves people and organizations forward. Throughout her career, she has expertly crafted complex quality management strategies for multi-billion-dollar matrixed organizations. Committed to the belief that patients and customers must have access to effective medicine, Robin intentionally chose the quality function within the pharmaceutical indutry.

Robin Kumoluyi is the Vice President and Chief Quality Officer, Pharmaceuticals at Johnson & Johnson Corporation. Robin has responsibility for Quality & Compliance for the Global Pharmaceuticals Segment in Pre-Market R&D, Supply Chain and Post Market Commercial. Prior to her current role, Robin was VP, Global Quality Services at Johnson & Johnson, where she drove the organization’s Enterprise Quality transformation by defining, leading, and executing the strategic direction and oversight of the Quality Policies, Standards, Digital Healthcare, Innovation and Analytics, Value Chain Quality, and the overall Q&C Strategy and associated processes.

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Peter Shearstone of Thermo Fisher Scientific — Changing the Compliance Paradigm in Large, Global Companies
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Peter Shearstone of Thermo Fisher Scientific — Changing the Compliance Paradigm in Large, Global Companies

As part of the 2024 edition of the Pharma Manufacturing World Summit we interviewed Peter Shearstone, Thermo Fisher Scientific’s VP Global Quality & Regulatory Affairs, about a themed lunch discussion he hosted that revolved around Compliance in the pharmaceutical space, especially as it related to companies with a worldwide footprint. How does Compliance shape the way businesses function? How is that changing over time? How did the pandemic change the way the pharmaceutical industry thinks about itself and problem-solves? What can large organizations learn from the capabilities and outlook of smaller and more nimble companies? What are the things global companies will always do well, but can still do better? What should every leader working in this space be thinking about and learning about and doing more of to improve themselves, their teams, and the industry as a whole? For all this and more, give this episode a listen!

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From Seed to Sip: Achieving Consistent and Sustainable Quality in World-Class Brewing
FOOD SAFETY & QUALITY, FOOD SAFETY & QUALITY, VIDEO

From Seed to Sip: Achieving Consistent and Sustainable Quality in World-Class Brewing

Kristopher Scholl is currently the Global VP – Brewing, Quality, & Raw Material Operations for AB-InBev. He started his brewing career at Anheuser-Busch in 1995 and has worked in various roles from a brewing intern to Sr. Brewmaster at the St. Louis, MO, Jacksonville, FL, and Baldwinsville, NY breweries. Additionally, Kris served as the Sr. General Manager for the Merrimack, NH and Newark, NJ breweries. He also worked as Director of Supply Performance Management for North America and as Global Director of Brewing & Quality. In 2013, Kris left ABI to pursue opportunities in the US craft beer industry where he led brewery operations at Deschutes Brewery and Craft Brew Alliance as well as The Bruery and Offshoot Beer Company as their Chief Operating Officer and Head of Finance. Kris rejoined AB-InBev in 2021 as the Global VP of Brewing and Quality where he currently directs brewery technical support, global raw material operations, and quality standards of the AB-InBev’s operations around the world. He leads the global taste panel of ABI which ensures the taste of ABI’s beers meet the exacting standards of quality and consistency consumers expect.

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Culture of Quality Excellence Driving Competitive Advantage for Operations
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Culture of Quality Excellence Driving Competitive Advantage for Operations

Why a Culture of Quality Excellence is foundational to achieving manufacturing excellence and leads to competitive advantage for operations. Driving a culture that recognizes the Value of Quality Excellence. How to establish a Culture of Quality Excellence by focusing not only on processes and digital infrastructure but also focusing on Real-world examples of how Quality excellence is translated into manufacturing excellence, including  Vendor Management, Investigational Excellence and End to End QMS. Using Quality data in a proactive and predictive manner in order to deliver value and achieve manufacturing excellence. — RJ Doornbos VP, Global Quality Systems Bristol Myers Squibb As the Head of Global…

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Establishing a ‘Culture of Data’ in Pharma Manufacturing
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Establishing a ‘Culture of Data’ in Pharma Manufacturing

Pharmaceutical manufacturers have worked diligently and successfully to foster a ‘culture of quality’, resulting in fewer overall regulatory citations year over year since 2010. How can better data management and analytics impact not only quality but process improvement and efficiency gains as well? What trends are driving the need to move towards both managing and using data better? The ‘culture of data’ starts with changing old ways of working. What steps do biopharma manufacturers need to take to initiate their transformation? How can manufacturers use manufacturing process data to quickly and proactively improve outcomes? — Vishaka Rajaram Director, Pharmaceutical and…

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Supplier Risk Management and Building Quality Culture within New Integrations
FOOD SAFETY & QUALITY, FOOD SAFETY & QUALITY, VIDEO

Supplier Risk Management and Building Quality Culture within New Integrations

How do you establish, nurture, and grow a culture of Quality in the midst of organizational disruption and transformation? Understanding that while change starts at the top, it needs to be built from the ground up Discussing how suppliers fit into the larger conversation of both risk management and Quality Culture during M&A activity — Carolyn Nguyen VP Global Quality & Compliance Programs Mondelēz International Carolyn is currently the Vice President of Global Quality and Compliance Programs for Mondelēz International, with responsibility for driving consistency in Consumer driven Quality across all of Mondelēz ’s Internal & external manufacturing sites and supply…

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A “One Team” Global Approach to Food Safety
FOOD SAFETY & QUALITY, FOOD SAFETY & QUALITY, VIDEO

A “One Team” Global Approach to Food Safety

Walmart has set a goal to become a regenerative company—one that places nature and humanity at the center of our business Our approach to food safety exemplifies this strategy as we seek to go beyond compliance and work collaboratively with others to strengthen food safety systems Science based food safety is universal. Working as one global team positions us to enhance the safety of food around the world confidently and consistently One case study will be shared – the redesign of our Private Brand food safety program including the Product Design Hazard Analysis (PDHA) approach; there is a positive outcome…

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The New Era of Food Safety Needs a Great Team with Strong Leadership
FOOD SAFETY & QUALITY, FOOD SAFETY & QUALITY, VIDEO

The New Era of Food Safety Needs a Great Team with Strong Leadership

Demonstrating that even before the global pandemic, people have always been the catalysts of change and the difference-makers in every aspect of our business, and especially when it comes to Food Safety, Quality, and Compliance How do you identify, support, and develop the future leaders of your organization to carry on the FSQ values your company is built upon? Mobilizing the unique culture of our team to embracing transformation and fresh perspectives while holding onto the best of what has always driven positive outcomes in turbulent times Creating a framework that encourages all employees to unlock their potential personally and…

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QSR Food Safety Culture: Building an End to End Food Safety System and the Culture to Sustain
FOOD SAFETY & QUALITY, FOOD SAFETY & QUALITY, VIDEO

QSR Food Safety Culture: Building an End to End Food Safety System and the Culture to Sustain

Strategies to embed food safety and quality standards across the supply chain Overcoming the challenges involved in building a responsible culture and how to navigate them Making the business case by Identifying long term benefits and how this journey will continue into the future — Steve Lutes VP, Global QA and Food Safety Domino’s Steve Lutes serves as Vice President, Global QA and Food Safety for Domino’s, the world’s largest Pizza company. Hired in March 2018 into this created global role, Lutes is responsible for leading the Quality Assurance team globally. Strategic initiatives he is leading include, driving culture change…

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Key Attributes of a Successful Quality Program
FOOD SAFETY & QUALITY, FOOD SAFETY & QUALITY, VIDEO

Key Attributes of a Successful Quality Program

Breaking down the silos and integrating Manufacturing, Supply Chain and R&D into your Food Safety program Strategies behind maintaining an effective brand management plan with Quality at the forefront Exploring ways to maximize flexibility and agility as business models change — Darryl Riley SVP Food Safety, Quality & R&D Hostess Brands Darryl Riley is the SVP Quality/ Food Safety and R&D for Hostess Brands, LLC and serves on the senior leadership team. He directs the strategic plan and risk management for food safety and quality including policy, practices, and procedures. He also directs the R&D team with headcount and budget…

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The Future of Biomanufacturing: Leveraging Flexible Networks, Quality Culture and Cutting Edge Innovation
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The Future of Biomanufacturing: Leveraging Flexible Networks, Quality Culture and Cutting Edge Innovation

 How biomanufacturing can address the dichotomy of small volume precision medicines and high volume blockbuster drugs Building flexible global manufacturing networks to meet our industry’s evolving needs Leveraging cutting edge innovation to maximize process intensification and augment flexibility Creating high performance teams and building and maintaining a culture of quality, reliability and innovation as key differentiator and foundation for continued success Please note: Q&A appears in this separate video: — Jens Vogel President & CEO, BI Fremont Inc. Boehringer Ingelheim Biopharmaceuticals GmbH Dr. Jens Vogel is President and CEO of Boehringer Ingelheim Fremont Inc., the US arm of Boehringer…

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Compliance, Quality, and Risk – A Conversation with Jack Garvey of Compliance Architects
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Compliance, Quality, and Risk – A Conversation with Jack Garvey of Compliance Architects

At the 2019 edition of the Biomanufacturing World Summit series earlier this month in San Diego we spoke with Jack Garvey, Compliance Architects’ co-founder and CEO. Jack has chaired the Quality stream of content for several Biomanufacturing World Summits, and he has deep insights to offer biopharmaceutical manufacturers looking to communicate with regulators and build their organizations to better address the issues of Compliance, Quality, and Risk. — Jack Garvey CEO Compliance Architects Jack Garvey is the Founder and Chief Executive Officer of Compliance Architects®, a leading consulting and advisory firm specializing in innovative quality and compliance solutions for FDA-regulated…

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Sustainable cGMP Compliance is Spelled with 4C’s
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Sustainable cGMP Compliance is Spelled with 4C’s

What do we mean when we talk about Quality Culture, and how has that changed over time? If we could start over from scratch, what would we want Quality Culture in our industry to look like? How do we move forward as leaders in our industry to harmonize the ideal with reality? Discussing the tools, tactics, techniques, and technologies we need to make part of this conversation Setting a challenging goal: What can we do next week to move forward with what we have discussed today? — Anders Vinther Global Head of Quality and Engagement Intarcia Therapeutics Prof. Wolfram Carius…

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