Director, Manufacturing Compliance (Fill/Finish)
Core
Lead the Fill/Finish Manufacturing compliance organization, overseeing Change Control, Manufacturing Investigations, and CAPA management to ensure GMP compliance and inspection readiness.
Role type
Director, Manufacturing Compliance (Fill/Finish)
Builds
Compliant aseptic biologics fill/finish operations for patients with serious diseases
Domain
Biopharmaceuticals / Aseptic Manufacturing / GMP Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP regulations expertise, Change Control management, Manufacturing Investigations leadership, CAPA management, Root cause analysis, KPI monitoring, Regulatory interaction, Team leadership, Strategic planning
Preferred skills
Multiproduct facility experience, Aseptic biologics environment experience, Cross-functional collaboration
Technologies
FDA 21 CFR Parts 210/211, EU GMP Annex 1, ICH Q10
Responsibilities
Lead and develop the Fill/Finish Manufacturing compliance organization; oversee Change Control and Manufacturing Investigations sub-teams; monitor and report team KPIs; conduct trend analysis on deviations; represent manufacturing at governance forums and health authority interactions; lead annual merit reviews and staffing plans; maintain site inspection readiness; write and approve SOPs and regulatory filings.
Seniority
Director, strategic leadership & team management
