Senior Quality Manager, Tijuana Operations
Core
On-site leadership role ensuring the effectiveness of the site's Quality Management System (QMS) and providing hands-on quality support to manufacturing operations.
Role type
Senior Quality Manager (Manufacturing)
Builds
Pharmaceutical/Scientific manufacturing products
Domain
Life Sciences / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management Systems (QMS), CAPA, complaints handling, nonconformance management, audits, root cause analysis, risk assessment, continuous improvement, data analysis, team leadership
Preferred skills
Regulated manufacturing experience, ISO/FDA/GMP knowledge, Lean/Six Sigma, Quality certifications (ASQ CQM/QE/SS)
Technologies
GMP, ISO, FDA standards
Responsibilities
Lead and maintain site Quality System processes; oversee CAPA, complaints, and nonconformances; lead internal and regulatory audits; maintain active presence on the manufacturing floor; drive Quality KPIs and performance metrics; lead continuous improvement initiatives; coach and develop the Quality team
Seniority
Senior, hands-on IC with leadership responsibilities