Audit & GMP - Logistics Training Lead 80-100% (m/w/d) — Lonza

Full description

Where necessary, eligible candidates and their families will be assisted in moving.

In this key position, you assume responsibility for ensuring sustainable GMP compliance within all logistics areas. As the central contact person for audit and inspection topics, you represent logistics to internal and external auditors, authorities and customers.

You ensure continuous audit readiness, develop training and qualification processes and promote a sustainable quality and GMP culture in everyday operations. You combine regulatory requirements with practical implementation directly on site and work closely with various specialist areas.

What we offer

• An Agile Career and Dynamic Work Culture
• An inclusive and ethical workplace
• Compensation programs that recognize high performance
• In addition to a competitive salary, you can expect numerous advantages in the areas of lifestyle, family and leisure. The full list of our global services can be found at: Benefits - Visp

Your tasks

• GMP Compliance, Audits & CAPA: You plan, coordinate and accompany internal and external audits as well as official inspections. You ensure permanent audit readiness and support in the investigation of deviations, root cause analyses and the definition and tracking of effective CAPAs. In addition, you accompany change control processes and ensure GMP-compliant implementation.
• Training & qualification: You are responsible for the training matrix for around 140 employees in the logistics sector and ensure that all required GMP, hygiene, safety and functional training is completed and documented on schedule. You coordinate training, monitor qualification levels and provide complete, audit-oriented training and qualification certificates.
• GMP Gemba Walks & Operational Presence: You carry out regular GMP Gemba Walks in the various logistics areas, identify risks and potential for improvement directly on site and initiate appropriate measures. You strengthen the quality awareness and the personal responsibility of the employees.
• Processes & Documentation: You create and maintain SOPs, work instructions and training materials and ensure their compliance with applicable quality standards and location requirements. In addition, you drive the continuous improvement of compliance and logistics processes.
• Onboarding, Offboarding & Collaboration: Ensure GMP-compliant entry and exit of employees, including the required training, qualifications and permissions. As a central interface, you work closely with Quality Assurance, Production, Supply Chain, Hygiene and the Central Warehouse.

Your profile

• Completed Bachelor's degree (BSc) in Life Sciences, Pharmacy, Chemistry, Biotechnology, Engineering, Logistics, Supply Chain Management or a related field. Alternatively, an equivalent vocational training with in-depth GMP experience in a regulated pharmaceutical, biotech or medical technology environment.
• In-depth knowledge of GMP requirements in logistics and warehousing as well as a good understanding of relevant standards and regulations, in particular ISO 9001, ISO 13485, EU/US GMP and 21 CFR Part 820.
• Several years or proven experience in the preparation and implementation of audits and inspections as well as in the areas of Deviation Management, Root Cause Analysis, CAPA and Change Control.
• Experience in training and qualification management as well as in the creation and maintenance of GMP-compliant documentation and in dealing with data integrity requirements.
• Good IT knowledge and secure handling of SAP, MES and document management systems (DMS); Experience with TrackWise is an advantage
• Strong analytical and structured working methods, high personal responsibility and the ability to identify risks and implement sustainable solutions.
• Communication strength and assertiveness as well as pleasure in working with different departments and hierarchical levels.
• You understand how to convey GMP requirements pragmatically and comprehensibly and convince teams even without direct leadership responsibility.
• Very good knowledge of German and English in word and writing.

At Lonza, our employees are our greatest strength. At more than 30 locations on five continents, our globally networked teams work together every day to produce the medicines of tomorrow. Our core values: collaboration, accountability, excellence, passion and integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s what we want you to share.

Innovation thrives when people from different backgrounds bring in their unique perspectives. At Lonza, we value diversity and are committed to an inclusive environment for all employees. If you are ready to translate our customers’ groundbreaking ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now!

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