 Serve as Primary Customer Contact in which the individual will respond to direct customer questions, customer notifications of issues/deviations, consistently give updates to on-going issues, and maintain/update customer Quality Agreements.Independently review, provide counsel, and/or approve customer complaints from initial intake through final resolution, ensuring timely investigation, root cause analysis, implementation of corrective and preventive actions (CAPA), and effective communication with customers and internal stakeholders.Perform review and approval of validations, qualifications and certificates of analysis.Independently evaluate, process, and implement change requests using formal change control processes, ensuring appropriate risk assessment, cross-functional alignment, documentation, and regulatory compliance.Perform comprehensive product and process risk assessments utilizing established quality risk management methodologies (e.g., FMEA, risk matrices) and implement appropriate mitigation and monitoring strategies.Plan, support, and actively participate in internal, customer, and regulatory audits by preparing documentation, facilitating audit activities, responding to audit observations, and ensuring timely completion of corrective actions.Build and maintain effective working relationships with cross-functional teams including Production, Technical Services (TS), Customer Services (CS), Engineering, Supply Chain, Plant Management, and external stakeholders such as customers, suppliers, and regulatory representatives.Lead or support the implementation of new products, manufacturing processes, technology transfers, continuous improvement initiatives, and other strategic projects while ensuring compliance with quality, cost, and timeline objectives.Maintain compliance with applicable international quality standards, regulatory requirements, customer-specific requirements, occupational health and safety regulations, and internal company policies, procedures, SOPs, and work instructions.Create, maintain, and continuously update Product Master Files (PMFs) and related technical documentation, ensuring all product, process, and transfer changes are accurately reflected and controlled.Monitor quality performance metrics, identify trends through statistical analysis, and recommend process improvements that enhance product quality, manufacturing efficiency, and customer satisfaction.Support continuous improvement initiatives by applying Lean Manufacturing, Six Sigma, or equivalent quality improvement methodologies where applicable.Prepare technical reports, quality summaries, management presentations, and customer communications to support decision-making and regulatory compliance. 
