Beschreibung

In this role, you will lead the global strategy for drug product manufacturing processes, ensuring compliance and quality through equipment qualification and validation. Your expertise will guide teams in implementing best practices and navigating regulatory inspections.

Anforderungen

• •Ph.D. in pharmaceutical sciences, engineering, biochemistry, or related field, or equivalent experience
• •Expertise in equipment qualification for aseptic drug product manufacturing
• •Extensive experience in process validation for sterile biologics, including lyophilized and liquid formats
• •Proven experience with regulatory submissions and pre‑approval inspections
• •Strong statistical skills for qualification, validation, and CPV; Data Science certification or Lean Six Sigma Black Belt preferred
• •Knowledge of risk assessment, deviation management, change control, and root cause analysis
• •Excellent English communication, documentation, leadership, and cross‑functional collaboration skills

Aufgaben

• •Lead global process control strategy for drug product manufacturing
• •Own global strategies for equipment qualification, process validation, and continued process verification
• •Define and govern global SOPs, standards, templates, and tools aligned with regulations
• •Own qualification strategy for thawing, compounding, filling, lyophilization, and crimping
• •Guide Tech Transfer and local MSAT teams on validation strategies and sampling plans
• •Review and approve validation documentation
• •Analyze production data using appropriate statistical methods
• •Act as subject-matter expert during health authority inspections

Benefits