Beth Crandall is the President and owner of BC Consulting, specializing in program management, organizational change and Quality Management System development and implementation for the life science industry.
Beth is a respected leader who started her consulting career in the Organizational Change Management practice within Andersen Consulting in the early 1990s. She brings over 20
years of experience in the life sciences industry, specializing in the regulated medical device market. She previously worked at Guidant Corporation and Boston Scientific in a variety of Information Technology, Software Life Cycle and Quality System positions. She has also served in project management roles throughout her career and has been a certified Project Manager (PMI PMP) since 2012.
She joined Maetrics in 2013, working as a program manager dedicated to an international medical device client. Beth rose through the ranks of the Solutions Delivery team to become a Global Solutions Delivery Leader and Managing Director. Maetrics merged with R&Q Solutions in June 2020, and the company was re-branded in January 2021 to RQM+ becoming the world's largest regulatory and quality consulting firm focused on medical devices and diagnostics. In the fall of 2021 she shifted her professional goals and established BC Consulting MN LLC.
Beth combines her consulting experience and expertise in life science, quality assurance, regulatory affairs, organizational change and project management to help clients in the global life science market. She earned a Bachelor of Arts degree from the College of St. Thomas in Business Administration, Human Resource Management. She has presented at several medical device conferences and published “A Blueprint for Quality” in MD&DI magazine in 2004. More recently Beth authored articles for multiple publications on the topic of the European Union’s Medical Device Regulation (EU MDR, 2017/745).
Beth has also maintained the rights to a paradigm-shifting approach she developed called “Prioritize Success”; consisting of two formulas The Professional Equation and The Objective Table, to helps organizations and individuals to evaluate success factors and prioritize efforts to maximize success.
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ExpertiseAs the regulatory landscape continues to shift with new regulations constantly being introduced, managing people, processes and technology is an increasingly complicated task. Companies need to remain agile in the complex world of compliance and managing regulatory change is a major focus for many global life science firms. Beth’s expertise lies in this crucial area that combines organizational change management with quality and regulatory compliance. She has a successful track record of leading large quality system programs and implementing changes to related policies, procedures, and software systems. She uses organizational change techniques to maximize productivity while achieving business and compliance objectives. Beth holds a unique skill set critical for transforming the chaos and challenges of regulatory changes into positive outcomes for organizational success. The focus is on effective solutions that transform the company culture, rather than a paper-work exercise that may not be understood or maintained.
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LeadershipShe places an emphasis on understanding ‘Context’ – an essential quality in consultancy leaders. She has an ability to understand how a situation has come to be and to provide an effective solution. This ability to excel in context means she can create a meaningful bridge between clients and their challenges. She also mentors client leaders in the organizational change techniques so their culture shift can be maintained. Training & communication is a particular personal strength. She is able to translate complex information to be understood by audiences of all levels and backgrounds. Clients and team members benefit from her ability and dedication to sharing knowledge and unpacking complicated concepts. She sees challenges and problems as a means for operational improvement. Beth’s positive attitude, adaptability and quality management training are key to providing innovative and tailored solutions for its clients. Beth’s leadership approach: “I am genuinely interested and want to make things better for people. Things don’t need to be as hard as we make them.” Her desire to lead effective change is born out of this goal to make anyone who she works with feel listened to and understood. She then partners with them to map out solutions and devise effective plans, showing them how they can create efficiencies.
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Who I amProven and respected leader, including executive level leadership roles Experienced program and project manager of large programs and projects with enterprise wide organizational impact PMP Certified since 2012 Experienced in multiple Organizational Change Management methodologies Over 20 years’ experience in regulated life science industry Extensive experience with and understanding of life science industry requirements, including those of the FDA, European Union and ISO standards (examples: CFR 820; ISO 9001, ISO 13485:2016, ISO 14971: 2019; EU MDR/IVDR) Over 17 years’ consulting experience, including large, medium and small firms Experienced assessor and auditor
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Who I helpDirector or VP level leaders with management responsibility for compliance within regulated Life Science industries (e.g. Medical Device, Diagnostics, Pharmaceutical) These are typically in the Quality or Regulatory function, but may also include leaders in Operations, R&D, Clinical or IT. Clients experiencing or undertaking changes such as: Acquisition or business integration Changing regulatory or business requirements Findings from a Regulatory Authority Business Growth Process improvement needed for to reduce costs or drive business efficiency Clients seeking leadership to departments, programs or projects during transitional situations, such as Interim VP or Director level leadership during search for full time resource Planning and execution of large Programs or projects impacting the Quality Management System in the Life Science industry
How I Help Clients
Conduct assessments or audits of current state organizations; Including organizational assessments using my exclusive methods.
Design and develop future state vision and strategy, including processes, systems and
organizational structure
Establish plans to transition from current state to future state
Execute programs or projects to achieve future state vision
Apply effective organizational change techniques to improve success rate of implementation
How I Do It
Utilize Organizational Change techniques
Apply project management discipline
Use proven process improvement and development methods
Utilize expertise in adult learning and communication
Provide a practical approach
Contact Me
2916 83rd Lane N
Brooklyn Park, MN 55444