Manager Training & Personnel Qualification (80-100%)

Ophtapharm AG; Hettlingen; On-site; CHF 140,000 - 190,000; Full time

Benefits offered by this job

Pension scheme

Free parking

Convenient public transport access

Job summary

Ophtapharm AG in Hettlingen near Winterthur develops and manufactures sterile ophthalmic medicines. The Manager Training & Personnel Qualification leads the site-wide GMP training, qualification standards and programs to ensure inspection readiness and patient safety.

You will drive digitalization of training processes, collaborate with Production, Quality, QC, Microbiology and Engineering, and support audits with data integrity. Fluent English and German are required for stakeholder engagement.

Qualifications

• Degree in a scientific discipline relevant to pharma manufacturing.
• Several years of GMP-regulated manufacturing experience, incl. sterile operations.
• Experience in training, qualification, and GMP quality systems.
• Strong knowledge of GMP training and compliance requirements.
• Familiarity with FDA/EU GMP and Annex 1 expectations.
• Experience with LMS/eQMS or similar digital quality systems.
• Fluent English and German communication, stakeholder engagement across levels.

Responsibilities

• Own and evolve the site-wide GMP training, competency and qualification framework.
• Define qualification standards, certification requirements and requalification programs.
• Lead risk-based training curricula, assessments and qualification pathways.
• Drive modernization and digitalization of training processes and LMS systems.
• Act as site expert for GMP training, partnering with Production, Quality, QC, Microbiology and Engineering.
• Support audits and quality improvement initiatives with training data integrity.
• Foster a culture of competency, accountability and continuous learning.

Skills

GMP-regulated manufacturing experience

Training & personnel qualification

Competency management

English & German communication

LMS/eQMS experience

Education

Degree in Pharmacy, Pharmaceutical Sciences, Microbiology, Biotechnology, Engineering

Tools

LMS

eQMS

Job description

At Ophtapharm AG, we develop and manufacture sterile ophthalmic medicines that help patients worldwide protect and improve their vision. As an FDA- and EU-GMP-certified pharmaceutical manufacturer based in Hettlingen near Winterthur, we combine high quality standards with a clear global mission.

Manager Training & Personnel Qualification (80-100%)

As part of our continued commitment to quality and compliance, we are strengthening our training and personnel qualification capabilities across the site. In this highly visible role, you will ensure that employees are appropriately trained, qualified and prepared to perform critical GMP activities while helping to modernize and enhance our training landscape. You will work closely with colleagues across Production, Quality, QC, Microbiology and Engineering, directly contributing to inspection readiness, sterility assurance and patient safety.

Your Role

• 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 the continued development of learning and training management systems.
• Act as the site expert for GMP training and personnel qualification, partnering with leaders across Production, Quality, QC, Microbiology and Engineering.
• 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 to strengthen product quality, sterility assurance and patient safety.

Your Profile

• Degree in Pharmacy, Pharmaceutical Sciences, Microbiology, Biotechnology, Engineering or a comparable scientific discipline.
• Several years of experience in GMP-regulated pharmaceutical manufacturing, including exposure to sterile or aseptic operations.
• Experience in training, personnel qualification, competency management or related GMP quality systems.
• Strong understanding of GMP training, personnel qualification and compliance requirements within pharmaceutical manufacturing.
• Good knowledge of FDA, EU GMP and Annex 1 requirements, ideally gained in a sterile manufacturing environment.
• Experience with LMS, eQMS or comparable digital quality and training systems.
• Fluent English and strong German communication skills, with the ability to engage stakeholders across all organizational levels.

What you can expect

• A highly visible role with direct impact on compliance, inspection readiness and product quality.
• The opportunity to modernize and shape the future of training and personnel qualification at a sterile manufacturing site.
• Close collaboration with experienced leaders and subject matter experts across the organization.
• A collaborative culture with short decision-making paths and the ability to turn ideas into action.
• An attractive pension scheme, free parking and convenient public transport access.