GMP Training & Qualification Leader

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

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.