Quality Control, Mgr
On-siteSão Paulo, São Paulo, Brazil
Job Summary
Lead daily operations of the Microbiology and Chemistry Laboratories, ensuring timely execution, review, and approval of testing activities while maintaining continuous inspection readiness for regulatory audits. Manage laboratory resources, staffing, and workload prioritization to support product disposition, batch release, and supply continuity in accordance with cGMP requirements. Drive root cause analysis, quality risk assessments, and CAPA development for OOS, OOT, deviations, and contamination events. Partner with Manufacturing, Engineering, Validation, and Regulatory Affairs to support aseptic processing controls, facility expansions, and process validations. Establish and monitor performance metrics, develop dashboards, and lead Lean Laboratory initiatives to improve workflow efficiency and reduce cycle times. Manage laboratory budgets, forecasting, and cost optimization while driving adoption of automation and electronic systems to enhance data quality and operational effectiveness.
Required Qualifications
- Bachelor's degree in Microbiology, Biology, Biotechnology, Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, Life Sciences, or related scientific discipline
- Advance level of English
- Minimum of 7-10 years of progressive experience in Quality Control, Microbiology, Analytical Chemistry, Pharmaceutical Manufacturing, Biotechnology, Medical Devices, Healthcare Manufacturing, or other regulated industries
- Minimum of 3-5 years of leadership experience managing laboratory operations, technical teams, or quality organizations
- Proven experience supporting regulatory inspections, customer audits, compliance remediation, and inspection readiness programs
- Experience leading microbiological and analytical investigations, contamination control strategies, environmental monitoring programs, quality risk management activities, and CAPA systems
- Strong background in cGMP laboratory operations, quality systems, method lifecycle management, equipment qualification, and data integrity requirements
Desired Qualifications
- Master's degree or other advanced scientific qualification
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