This role provides QA oversight and timely quality guidance for drug substance development activities and GMP manufacturing performed at external CMOs
Job Summary
This role provides QA oversight and timely quality guidance for drug substance development activities and GMP manufacturing performed at external CMOs.
The successful candidate will collaborate closely with internal development functions and external partners to ensure alignment, compliance, and effective issue resolution.
Zealand Pharma offers a unique culture characterized by excellent teamwork, strong engagement, and a focus on bonding through curiosity and playfulness.
Matching Summary
This role provides QA oversight and timely quality guidance for drug substance development activities and GMP manufacturing performed at external CMOs.
Skills & Requirements
Must-have
Drug substance GMP operations experience
QA oversight of external CMOs
CMC project team collaboration
GMP documentation review and approval
Health authority inspection readiness
Nice-to-have
Pragmatic approach to quality judgment
Strong stakeholder communication skills
Willingness to travel occasionally
Experience in outsourced business models
Key Requirements
Master's degree in life science or pharmacy
Several years of drug substance GMP operations experience
Solid understanding of GMP requirements and Quality Systems