Torsten Kneuss
Lead Pharma Device & Maastricht Quality @Bayer
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WORK HISTORY
Lead Pharma Device & Maastricht Quality @Bayer
Berlin, DE
As a VACC (Visionary, Architect, Catalyst, and Coach) Leader, I lead a team of quality professionals located across Costa Rica, Germany, and the Netherlands, specializing in Medical Devices and Combination Products.My team’s expertise spans a broad range of areas, including- Complaint Management- Design and Development- Risk Management- Establishing and Maintaining Quality Management Systems for Medical Devices- Responsibilities of Distributors, Importers, and Authorized Representatives of Medical DevicesIn addition to my leadership responsibilities, I serve as the Person Responsible for Regulatory Compliance (PRRC) for Bayer AG and its Swiss affiliates.A significant aspect of my role involves managing audits conducted by Notified Bodies, ensuring compliance with rigorous regulatory standards. I am also actively involved in conducting internal audits and overseeing audits of suppliers and third-party entities, with a focus on medical devices and related services, including packaging materials.My work is driven by a steadfast commitment to upholding the highest standards of quality and compliance, ensuring patient safety, and fostering continuous improvement across our operations—all aligned with Bayer’s inspiring vision: “Health for all, Hunger for none.”
EDUCATION
Hochschule für Technik und Wirtschaft, Berlin
degree (Dipl.-Wirtsch.-Ing.), business administration and engineering
SKILLS
ABOUT TORSTEN KNEUSS
With nearly 30 years in the pharmaceutical industry, I specialize in ensuring product quality, patient safety, and regulatory compliance across pharma, medical devices, and combination products. I combine deep quality and regulatory expertise with hands-on software and IT capabilities to drive efficient, compliant, and scalable systems at Bayer and beyond.# What I’m known for- 15+ years in leadership roles, guiding cross-functional teams and quality managers- Safeguarding license to operate through robust, compliant quality systems- Strengthening the Bayer brand via risk-based, audit-ready quality governance- Translating complex regulations into pragmatic processes and digital solutions# Core domains- Combination Products (Drug–Device) and Medical Devices- Pharmaceutical Packaging Systems and Device Development- External Manufacturing, Quality Management, and Quality Control- Pharmacovigilance, Device Vigilance, and Post-Market Surveillance# Methods and frameworks- ISO 13485 Quality Management Systems- ISO 14971 Risk Management- Regulatory frameworks for Combination Products- PMS/Vigilance systems and audit/inspection readiness# Digital and IT capabilities- Software development (Python, Django) and modern web architecture- Data-driven, risk-based quality processes and automation- Secure, scalable IT solutions aligned with compliance requirements# How I create impact- Spearheading interdisciplinary initiatives that streamline compliance and improve time-to-decision- Embedding digital tools to enhance efficiency, accuracy, and traceability- Coaching teams toward modern quality leadership with empowerment and accountability— If you’re interested in collaborating on quality leadership, combination products, or digital quality transformation, let’s connect here on LinkedIn or reach out via email to discuss opportunities and ideas.
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