Own end-to-end quality management for the Associate Manager, Quality role within the Life Science division, ensuring compliance with ISO, GMP, and applicable regulatory standards. Lead cross-functional teams to embed quality practices throughout the product lifecycle and drive continuous improvement. Establish KPI-driven dashboards to monitor quality performance and progress toward strategic objectives. Maintain accountability for audit readiness, third-party certifications, and robust documentation practices. Collaborate with manufacturing and supply chain to conduct risk assessments and perform root cause analysis on customer complaints and non-conformances. Implement robust CAPA processes to prevent recurrence and drive corrective actions across functions. Coordinate Factory Acceptance Tests (FAT) with customers and ensure complete documentation packages for final product delivery. Promote a culture of safety, sustainability, and operational excellence while mentoring the team and aligning goals with the broader organizational mission.
Who You Are.
You bring 8 or more years of experience in quality assurance or quality systems within regulated manufacturing environments, supported by a degree in Mechanical Engineering, Instrumentation Engineering, or related discipline. You have solid working knowledge of GMP and ISO standards, with hands-on experience managing quality management systems, document control workflows, and regulated deliverables across the product lifecycle. You hold a Lean Six Sigma Green Belt certification (Black Belt preferred) and have applied structured methodologies to drive measurable process improvements in manufacturing or packaging operations. You demonstrate proven capability in CAPA management, root cause analysis, non-conformance handling, and validation activities including IQ, OQ, and PQ with an understanding of CSV concepts. You have experience preparing for and managing external audits, ins