The Senior Quality/Innovation Project Manager is primarily responsible for managing the pipeline of tubular projects and their associated quality aspects, as well as enhancing the current portfolio. This role involves defining and implementing action plans to improve quality standards for existing tubular parenteral packaging, such as vials and ampoules, as well as for new developments like microvials and dual-chamber solutions. Additionally, the manager will lead the validation and deployment of new quality processes and technologies. Project Quality Management • Drive the management of the tubular quality innovation pipeline, from idea generation to implementation, to continuously improve product quality and performance. • Define and implement action plans to improve quality standards for tubular parenteral packaging (AQL, vials, ampoules). • Develop and roll out quality standards for products under development (e.g., microvials, dual-chamber solutions). • Lead the validation and industrialization of new quality processes and technologies. • Coordinate cross-functional project teams (Quality, Production, R&D, Regulatory, Purchasing). • Support regulatory compliance and ensure alignment with industry standards. • Propose and support investment projects related to quality innovation. • Conduct risk assessments related to new technologies or quality improvements. • Monitor and report progress of innovation projects to internal stakeholders (local and international). • Participate in project kick-offs, risk assessments, and reviews for new tubular developments. • Translate customer requirements (URS, technical specs) into clear quality deliverables (control plans, testing protocols). • Define and validate project-specific quality control methods (visual inspection criteria, dimensional controls, cosmetic standards) for tubular glass products. • Develop, maintain, and optimize quality documentation in collaboration with the Quality and Production teams. • Apply project management methodologies (e.g., Stage-Gate) to ensure quality milestones are achieved. • Establish acceptance criteria for dimensional (AQL), cosmetic, and functional specifications specific to tubular glass containers. Product and Process Validation • Plan and execute validation activities (IQ, OQ, PQ) for processes related to tubular glass new projects and products. • Analyze validation data, interpret results, and issue comprehensive validation reports with recommendations for improvement. Customer and Regulatory Compliance • Ensure compliance with cGMP, ISO 15378, ISO 9001, and customer-specific requirements. Cross-Functional Collaboration • Act as the key quality interface between Quality, Innovation, R&D, and Operations during project execution. • Support root cause analysis and implement corrective and preventive actions (CAPA) for project-related issues.
