Bernhard Thurnbauer personal email
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I have 30 years of experience in the pharmaceutical and information technology industry. I am a system thinker and visionary leader with vast international experience working in European, Asian, African, and North American markets. I obsess over learning, knowing that both success and failure push us forward, and accept calculated risk as the only path to impact. I am known for serving high-performing teams and developing strong collaborative partnerships. I am passionate about driving positive change in the healthcare system, people, diversity & inclusion. KEY AREAS OF EXPERTISE:• Strategy & Transformation• Global Program/Project Management• Quality & Compliance• Information TechnologyWHY IT WORKS: I’m a knowledgeable strategist and effective leader, particularly in times of organizational crisis, economic uncertainty, or industry shifts. WHAT MAKES ME DIFFERENT: I thrive in fast-paced, dynamic environments where I can lead and drive change in alignment with key business objectives. WANT TO TALK? Connect with me here on LinkedIn.
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Chief Quality OfficerOnesourceKarnataka, India
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Global Audit Program DirectorModerna Feb 2023 - PresentCambridge, Massachusetts, Us -
Global Head Of Quality And Compliance AuditsRoche Jul 2022 - PresentSwitzerland 🇨🇭 , Ch -
Regional Head Of Quality And Compliance Audit EmeaRoche Mar 2016 - PresentSwitzerland 🇨🇭 , ChIn this global executive quality assurance and compliance role, I assure site and functional compliance by all internal and external manufacturing sites (CMOs) to all applicable rules and regulations across Europe, Middle East and Africa (EMEA).Key Achievements:• Transforming the Quality & Compliance function from a ‘police presence’ into a business-enabling • partner.• Building a strong Quality culture across the organisation by becoming a trusted partner to all business lines/platforms through education and promoting a “first-time-right” mind-set.• Visibly developing corporate culture through effective leadership and implementing effective people management and development practices• Ensuring outstanding performance by attracting, developing, and retaining talent in key positions and developing succession plans to meet changing business needs while maintaining a positive and engaging employee relations environment.
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Regional Head External Quality Steriles & Packaging EmeaRoche Oct 2013 - Feb 2016Switzerland 🇨🇭 , ChIn this executive quality assurance role, I led a highly effective quality and compliance oversight program for drug products manufactured at multiple Contract Manufacturing Organizations (CMOs) in Europe. Notably, I led an initiative to mitigate quality and compliance risks related to data integrity issues at CMOs for Small Molecules External Quality.Key Achievements:• Passed various inspection with no 483s related to data integrity issued.• Improved “poor” quality and compliance standards at a key CMO to an acceptable level, achieving considerable savings and enabling greater flexibility in operations.
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Senior Quality Site Manager - External QualityRoche Feb 2012 - Oct 2013Switzerland 🇨🇭 , ChIn this senior site management role, I led quality control efforts related to drug products manufactured at a key Contract Manufacturing Organization (CMO) in France.Key Achievements:• Eliminated backlogs in complaints and product quality reviews; reduced new complaints• Increased on-time delivery by 30 percent
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Interim Manager, Head Of Quality Assurance And Qualified Person (Qp)Various Companies Jan 2011 - Apr 2014Greenwich, Ct, UsIn the various interim roles, I bridged management bottlenecks in the case of a lack of capacity or a lack of competence and managed short-term projects requiring specific management competencies. These roles required a significant amount of commercial awareness and business management and a QP as ‘business partner’. Key Achievements:• Ensured business continuity in global supply chains by designing and executing robust and successful Health Authority inspection management strategies.• Assumed responsibility for all stages of IMP supply, including audits of the supply chain for GMP compliance in addition to certification of products for use in clinical trials.• Assessed and enhanced quality assurance operations. -
Quality Site Head And Lead Qualified Person (Qp)Acino Pharma Ag Aug 2009 - Dec 2010Zurich, Switzerland, ChIn this senior quality assurance management role, I developed and managed the regulatory compliance and batch release functions for transdermal and implantable drug delivery systems, ensured all business units met all of their regulatory requirements and oversaw the establishment of practice standards throughout their activities.Importantly, I implemented ISO 13485 and US FDA regulations, increased on-time delivery by 20 percent to 98.5 percent or better as well as developing and implementing improved processes through collaboration with cross-functional teams in production, engineering, and quality. -
Qualified Person (Qp), Qualified Person For Pharmacovigilance (Qppv) And Deputy Head Of QcCnp International Gmbh Jan 2008 - Jul 2009My principal role was Head of International Business Development. However, as the need arose in March 2008, I took on the additional role as Responsible Person for Distribution for another company in the MIP Group. In April 2008, I took on the role of Qualified Person for two further entities within the group. In July 2008, my role expanded yet again to include Qualified Person for Pharmacovigilance and Deputy Head of QC.Key Achievements:• Resolved serious compliance problems with the companies top-selling product and resolved resolve disputes with the local competent authority.
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Founder And Managing DirectorFactorytalk Co.,Ltd. Oct 2004 - Dec 2007Bangkok, ThAs managing director of my own firm, I founded and built one of Thailand’s top manufacturing, IT, and compliance consultancies specializing in the pharmaceutical/biotech industries. I managed and supported clients’ global MES implementations and CSV projects as well as negotiating and securing contracts that produced a CAGR of 30-50% annually. -
Senior Vice President Of Strategic Marketing And Business Development, Business Manager Asia PacificPropack Data / Rockwell Automation Mar 2001 - Aug 2004In this executive role, I was responsible for setting up the company’s APAC unit from scratch. I led Asia Pacific sales & marketing activities, assessed new opportunities for the company, and directed alliance activities, resulting in a CAGR of 30%.
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Project Manager Global Marketing, Cosmetics And VitaminsF. Hoffmann-La Roche Ag, Basel, Switzerland Sep 2000 - Feb 2001Switzerland 🇨🇭 , ChIn this global project management role, I assisted in the set-up of a new marketing and sales channel for vitamins and cosmetics, including evaluating and recommending advertising agencies, performing the competitive analysis, and identifying take-over candidates.
Bernhard Thurnbauer Skills
Bernhard Thurnbauer Education Details
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Julius Maximilians University Of WürzburgPharmacy -
University Of BaselPharmaceutical Quality Assurance
Frequently Asked Questions about Bernhard Thurnbauer
What company does Bernhard Thurnbauer work for?
Bernhard Thurnbauer works for Onesource
What is Bernhard Thurnbauer's role at the current company?
Bernhard Thurnbauer's current role is Chief Quality Officer.
What is Bernhard Thurnbauer's email address?
Bernhard Thurnbauer's email address is bt****@****ail.com
What schools did Bernhard Thurnbauer attend?
Bernhard Thurnbauer attended Julius Maximilians University Of Würzburg, University Of Basel.
What skills is Bernhard Thurnbauer known for?
Bernhard Thurnbauer has skills like Gmp, Validation, Quality Assurance, Technology Transfer, Quality System, Supply Chain, Process Improvement, Change Management, Strategic Planning, Pharmaceutics, Change Control, Supply Chain Management.
Who are Bernhard Thurnbauer's colleagues?
Bernhard Thurnbauer's colleagues are Tommie Brown, Julie Bowersox, Mary Ann Pena, Malinda Smith, Vetrivelu Palanisamy, Shaik Rizwana, Bob Goldman.
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