Silvia Brodini

Strategic leadership of QA activities for Automation and Maximization projects, ensuring GMP compliance, regulatory alignment, and operational excellence across packaging and production functions. Key responsibilities:

• Oversight of QA compliance for new projects and tech transfers, ensuring adherence to regulatory requirements, Company directives, and Product Specifications.
• Leadership of Quality Operations for packaging in Maximization projects, including monitoring milestones, risk mitigation, and on-time deliverables.
• Point of contact with internal and external stakeholders, supporting regulatory strategy, Health Authority submissions, and site inspection readiness.
• Collaboration with Compliance teams to ensure Data Integrity and adherence to cGMP, ISO 13485, and 21 CFR Part III standards.
• Management of investigations, deviations, complaints, and change control related to automation and packaging projects, ensuring thorough root cause analysis and corrective/preventive actions.
• Supervision of aseptic process simulations, line/process startups, and validation protocol/reports review.
• Governance of SOP lifecycle management, staff training programs, and contractor oversight to ensure compliance with GMP, EHS, and internal/corporate procedures.
• Proactive support in implementation of new regulatory requirements and preparation for recurring regulatory inspections.
• Reporting of QA data to facilitate timely decision-making and maintain cross-functional alignment.

The role ensures end-to-end QA compliance, operational efficiency, and regulatory readiness across all automation and packaging initiatives.

Supervision and coordination of the QA Business Unit dedicated to aseptic filling and packaging activities, including:

• Planning and monitoring of QA Batch Record Review (BRR) and preparation for Qualified Person (QP) release;
• Management of minor and major quality events with focus on prompt impact assessment on both manufactured batches and production areas;
• Key contributor during Regulatory Authority and Customer inspections, acting as primary Quality System interface;
• Drafting and review of Risk Assessments related to Quality Assurance activities (e.g., second person verification rules, simplification of BRR responsibilities and procedures);
• Active involvement in digitalization initiatives and MES implementation projects.

Leadership and strategic oversight of the Quality System Compliance area, with accountability for:

• Governance and continuous improvement of the Quality Management System, including GMP training strategy and SOP lifecycle management in alignment with Corporate Policies and Standards;
• Accountability for Supplier Quality Management, covering supplier qualification and re-qualification, Quality Agreements, and supplier performance oversight;
• Governance of Internal Audit programs and ongoing GMP compliance surveillance;
• Key contributor during Regulatory Authority and Customer inspections, acting as primary Quality System interface;
• Oversight of compliance-related risk assessments (e.g. cross-contamination, mix-up risks, introduction of new Active Ingredients on existing manufacturing lines);
• Development and performance management of team members through coaching, structured training plans, and formal mid-year and annual evaluations.

Strategic leadership of the Quality on the Floor function, ensuring GMP compliance and operational excellence across manufacturing activities, with accountability for:

• Definition and execution of risk-based daily GMP surveillance across filling, visual inspection and packaging operations, driving prevention and reduction of quality events;
• Governance of shop-floor quality event management, ensuring rapid impact assessment on products and manufacturing areas and effective implementation of CAPAs;
• Oversight and optimization of Batch Record Review (BRR) processes, ensuring “Right First Time” execution and on-time completion aligned with business targets;
• Leadership of the AQL statistical inspection function downstream of 100% visual inspection, a critical step for batch release, including resource planning, qualification management and data integrity;
• Strategic support to Quality Operations for deviations, complaints and CAPA management, contributing to the “zero past due” quality objectives;
• Active representation of Quality during Regulatory Authority inspections and Customer audits;
• Driving quality performance KPIs, including “Right First Time”, “On Time Delivery” and continuous improvement of shop-floor quality processes;
• People leadership and talent development through structured training programs, coaching and performance management (mid-year and annual performance review processes for the assigned team);
• Accountability for .

• Strategic oversight of Quality Compliance activities supporting PDS projects, with direct accountability for assigned projects and leadership of the dedicated team, including:
• Governance of quality compliance for PDS projects, ensuring GMP alignment throughout project lifecycle;
• Definition and delivery of targeted training programs for personnel involved in PDS quality activities;
• End-to-end management of deviations and customer complaints, driving timely investigations and effective CAPA implementation in collaboration with cross-functional leadership;
• Proactive risk management through preparation and review of GMP risk assessments impacting PDS projects;
• Active participation in project governance and progress meetings, contributing to quality-driven decision making;
• Strategic collaboration with PDS stakeholders to support customer interactions, technical meetings and overall client management;
• Direct engagement in customer visits and representation of Quality during Customer and Regulatory Authority audits (AIFA, FDA, ANVISA, PMDA/Japan);
• Monitoring and reporting of quality performance metrics for PDS projects (e.g. Right First Time, On Time Delivery);

GMP review and approval of Master Batch Records (MBR) during drafting and lifecycle management liquid pharmaceutical products manufactured for Clinical Trials (Phases I–III) and Commercial supply. Acting as QA reference for assigned projects and customers, ensuring full compliance across manufacturing activities. Key responsibilities include:

• GMP review and approval of Master Batch Records (MBR) during drafting and lifecycle management
• Authoring and approval of raw materials, primary packaging and finished product specifications
• Preparation and maintenance of Product Specification Files (PSF)
• Review and negotiation of Customer Quality Agreements
• QA review and release support of electronic batch records (eBRs) for clinical, commercial and media fill productions
• Management of deviations, complaints and related investigations, including root cause analysis and CAPAs
• Evaluation and approval of change controls impacting PDS manufacturing areas and projects
• Authoring and review of GMP risk assessments for manufacturing and project activities
• Active participation in Customer and Regulatory Authority audits (AIFA, FDA, ANVISA, PMDA – Japan) as QA Subject Matter Expert
• Provision of senior QA support to customers on quality and compliance topics via meetings and teleconferences
• Participation in technical, quality and management meetings, acting as interface between QA, Production, QC and Project Management

Management and maintenance of the Quality Management System, with responsibility for:

• Drafting, review and governance of Standard Operating Procedures (SOPs);
• Planning and coordination of staff training programs;
• Supplier Quality Management activities;
• Preparation of technical specifications for raw materials and primary and secondary packaging;
• Drafting and review of Master Batch Records;
• End-to-end management of complaints, deviations and change control processes.

• Drafting of PQRs for sterile products (cytotoxic and non-cytotoxic anticancer drugs and solvent vials), including data analysis and trending, CAPA follow-up, and management of deviations and customer complaints.

• Preparation of APRs for liquid and lyophilized sterile products, including data collection, analysis, trending, and CAPA monitoring.
• Supplier management activities include supplier qualification, performance monitoring, complaint handling, and trend reporting.
• Oversight of staff training programs and SOP management.

• Production of synthetic intermediates for the Sanofi-Aventis Research Center located at Milan