Related skills
validation document control gxp gmp qms📋 Description
- Process alignment: resolve site quality process differences (CAPA, Change Control, Deviations, Document Control, Validation).
- Synergy optimization: foster cross-site collaboration to reduce duplication and speed cycles.
- Initiative oversight: govern three major site initiatives with alignment and risk controls.
- Strategic advisory: align priorities and advise on integration sequencing.
- Centralization guidance: advocate standards, templates, shared services to cut costs.
- Data & reporting: deliver executive dashboards on progress, risks and decisions.
🎯 Requirements
- Education: Bachelor’s/Master’s in Quality, Engineering, Life Sciences, or related field.
- Experience: 8–12+ years in multi-site quality leadership/integration in GMP/regulatory settings.
- Certifications: Lean/Six Sigma (Green/Black Belt), PMP or Prince2.
- Enterprise mindset: prioritizes network-wide outcomes over site silos.
- Bias for action: advances initiatives with disciplined execution.
- Structured problem solving: resolves conflicts using evidence and clear logic.
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