Manager Training & Personnel Qualification

About the role

Ophtapharm AG develops and manufactures sterile ophthalmic medicines near Winterthur, Switzerland, and is strengthening its training and personnel qualification capabilities. In this highly visible role you will ensure employees are trained, qualified and ready for critical GMP activities, working closely with colleagues in Production, Quality, QC, Microbiology and Engineering to support inspection readiness, sterility assurance and patient safety.

Key responsibilities

• Own and continuously evolve the site-wide GMP training, competency and personnel qualification framework, ensuring compliance, inspection readiness and operational effectiveness.
• Define and govern qualification standards, certification requirements and requalification programs for critical GMP activities across Production, QC and Microbiology.
• Lead the development of risk-based training curricula, competency assessments and qualification pathways aligned with regulatory expectations and business needs.
• Drive the modernization and digitalization of training and qualification processes, including learning and training management systems.
• Act as the site expert for GMP training and personnel qualification, partnering with leaders across departments.
• Support audits, inspections and quality improvement initiatives by ensuring training effectiveness, qualification compliance and data integrity.
• Establish a culture of competency, accountability and continuous learning.

Required profile

• Degree in Pharmacy, Pharmaceutical Sciences, Microbiology, Biotechnology, Engineering or a comparable scientific discipline.
• Several years of experience in GMP-regulated pharmaceutical manufacturing, including sterile or aseptic operations.
• Experience in training, personnel qualification, competency management or related GMP quality systems.
• Fluent English and strong German communication skills.

Required skills

• Strong understanding of GMP training, personnel qualification and compliance requirements.
• Good knowledge of FDA, EU GMP and Annex 1 requirements, ideally from a sterile manufacturing environment.
• Experience with LMS, eQMS or comparable digital quality and training systems.

What we offer

• A highly visible role with direct impact on compliance, inspection readiness and product quality.
• The chance to modernize training and personnel qualification at a sterile manufacturing site.
• Close collaboration with experienced leaders and subject matter experts.
• An attractive pension scheme, free parking and convenient public transport access.