Global MSAT Drug Product Qualification and Validation Lead 80-100% (m/f/d)
Core
Lead global process control strategy and validation for aseptic drug product manufacturing, including equipment qualification and process verification for sterile biologics.
Role type
Senior IC pharmaceutical process validation and qualification lead
Builds
Validated manufacturing processes and equipment for sterile biologics (lyophilized and liquid formats)
Domain
Life sciences / Pharmaceutical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Equipment qualification for aseptic manufacturing, process validation for sterile biologics, regulatory submission experience, statistical analysis for CPV, risk assessment, deviation management, change control, root cause analysis
Preferred skills
Data Science certification, Lean Six Sigma Black Belt
Technologies
None explicitly stated
Responsibilities
Lead global process control strategy for drug product manufacturing, Own global strategies for equipment qualification (PQ), process validation (PPQ), and continued process verification (CPV), Define and govern global SOPs and standards, Guide Tech Transfer and local teams on validation strategies and scale-up, Review and approve validation documentation and analyze production data, Act as subject-matter expert during health authority inspections
Seniority
Senior, hands-on IC
