Head of Qualification Support
Core
Lead qualification, validation, and computerized systems compliance strategies for global cGMP pharmaceutical manufacturing operations.
Role type
Senior executive quality assurance leader (Head of Qualification Support)
Builds
Global quality engineering practices and compliance across international regulatory standards
Domain
Pharmaceutical manufacturing / cGMP / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance leadership, team leadership and development, end-to-end lifecycle QA oversight, global harmonization, regulatory compliance and inspection readiness, data integrity and process improvement, cross-functional stakeholder alignment
Preferred skills
Strategic and analytical skills, communication and influence
Technologies
FDA, Swissmedic, EMA, ICH, PIC/S, EU, US regulatory standards
Responsibilities
Maintain accountability for qualification and validation compliance across equipment, facilities, utilities, and computerized systems; Direct and mentor multidisciplinary QA C&Q teams; Oversee complete commissioning and qualification (C&Q) lifecycles; Serve as senior Global QA representative in global forums; Translate evolving global regulatory guidance into actionable quality strategies; Evaluate and strengthen data integrity practices; Partner with Global and Site Engineering Leads and site QA teams
Seniority
Executive, strategic leadership & mentorship
