Senior Manager, Quality Control São Paulo, São Paulo

Job description

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Your role at Baxter The Sr. Quality Control Manager provides strategic, technical, operational, and people leadership for the site Quality Control organization, including the Chemistry and Microbiology Laboratories. The role ensures compliant, timely, and scientifically sound testing of raw materials, in-process materials, finished products, stability samples, water systems, utilities, and environmental monitoring programs, supporting product quality, patient safety, batch disposition, regulatory compliance, and uninterrupted supply. This leader is accountable for QC performance, data integrity, contamination control, investigations, inspection readiness, and continuous improvement. As a member of the site Quality leadership team, this role serves as the senior QC subject matter expert and primary QC representative to regulators, customers, Global Quality, and site leadership, and builds a high-performing leadership bench within the laboratories. Also owns the end-to-end transformation and improvement of Quality Control as a whole. Every process currently in place in the Physical-Chemical and Microbiological laboratories, from sampling and testing to investigations, data review, and reporting, will be assessed, redesigned, and modernized under this role's leadership, applying Lean, Six Sigma, and other operational excellence methodologies. Key Responsibilities Strategy and Leadership • Define and execute the QC strategy, roadmap, and multi-year capability plan aligned with site, quality, and business objectives. • Lead, coach, and develop laboratory leaders and their teams. Own succession planning, talent development, performance management, and engagement across both laboratories. • Build a culture of scientific excellence, accountability, quality ownership, and patient focus. • Represent QC in site governance forums, management reviews, and quality councils, providing data-driven recommendations to senior leadership. QC Transformation and Continuous Improvement • Own and lead the end-to-end transformation of Quality Control, accountable for assessing, redesigning, and improving all processes in the Physical-Chemical and Microbiological laboratories. • Define the QC transformation roadmap with clear scope, milestones, targets, and governance, sponsoring and reporting progress to site and Global Quality leadership. • Lead the deployment of Lean, Six Sigma, and Lean Laboratory methodologies (value stream mapping, DMAIC, 5S, standard work, visual management, Kaizen) across both laboratories. • Drive process standardization, harmonization, and simplification between Chemistry and Microbiology, eliminating waste, rework, and non-value-added activities. • Set and track improvement targets for turnaround time, investigation cycle time, right-first-time, capacity utilization, and cost, and sustain results through control plans and daily management. • Champion automation, digitization, and new analytical technologies as enablers of the transformation, ensuring compliance and data integrity are built into redesigned processes. • Develop internal continuous improvement capability by certifying and coaching Green Belts and project leaders, and by embedding an improvement mindset in laboratory teams. • Lead change management and communication to engage laboratory teams, Manufacturing, QA, and other stakeholders throughout the transformation. Laboratory Operations and Supply Continuity • Ensure timely, compliant execution, review, and approval of testing per approved methods, specifications, sampling plans, regulatory filings, and cGMP requirements. • Align QC priorities with Manufacturing, Supply Chain, and Quality Assurance to support batch disposition, release, and supply continuity. • Oversee capacity assessments, workload prioritization, staffing, and long-range resource planning for growth, new product introductions, and business continuity. Compliance, Data Integrity, and Inspection Readiness • Maintain both laboratories in continuous inspection readiness. Lead QC participation in regulatory inspections, customer audits, internal audits, and corporate assessments, including response and remediation. • Ensure data integrity across documentation, calculations, records, chromatography platforms, computerized systems, electronic records, and audit trails. • Ensure procedures, specifications, methods, and training remain current and compliant with regulations and company standards. • Ensure appropriate qualification, calibration, maintenance, and lifecycle management of laboratory equipment and computerized systems. Investigations and Quality Risk Management • Provide executive oversight and final approval for OOS, OOT, laboratory deviations, invalid tests, equipment failures, and data integrity concerns. • Ensure robust management of microbiological investigations, including EM excursions, contamination events, sterility failures, utility excursions, and adverse trends. • Ensure rigorous root cause analysis, risk assessments, CAPA, and effectiveness verification, with timely escalation of risks to product quality, patient safety, compliance, or supply. • Monitor trends and performance metrics to identify systemic issues and drive preventive improvements. Technical Leadership • Provide technical leadership for analytical methods (lifecycle, validation, verification, transfer), laboratory controls, and instrumentation. • Provide technical leadership for contamination control strategy, environmental and utility monitoring, sterility assurance, water system microbiology, and aseptic processing support, including site contamination control governance. • Support stability programs, annual product reviews, process and cleaning validation, product transfers, new product introductions, facility expansions, and equipment qualifications. • Partner with Manufacturing, Engineering, Validation, Technical Services, R&D, and Regulatory Affairs on risk assessments, process improvements, and facility design reviews. Financial Management and Operational Excellence • Develop, manage, and optimize the annual QC operating budget. Lead forecasting, spending oversight, and cost-reduction opportunities. • Build business cases and ROI assessments for new technologies, automation, instrumentation, and digitization initiatives. • Drive Lean Laboratory and operational excellence programs to reduce cycle times, improve right-first-time performance, eliminate non-value-added activities, and increase productivity. • Establish and monitor KPIs and dashboards (turnaround time, investigation cycle time, EM trends, right-first-time, compliance indicators). • Evaluate and implement analytical technologies, automation, and digital laboratory tools, including electronic laboratory systems and automated data review. What you'll bring • Bachelor’s degree in chemistry, Microbiology, Biology, Biotechnology, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline required. • Master's or advanced scientific degree preferred. • Progressive experience in Quality Control, Analytical Chemistry, Microbiology, or Quality Assurance within pharmaceutical, medica