Silvia Silva

Responsible for quality oversight of oncologic products at several External Contract Manufacturing Organizations (CMOs)

• Manage end-to-end quality oversight for both commercial and clinical products, ensuring alignment with regulatory standards and uninterrupted product supply
• Specifically DS and DP manufacture of Antibody Drug Conjugates (ADCs) (drug product filling – sterile manufacture of injectables)
• Lead complex deviations resolution, implementing change controls, and overseeing Corrective and Preventive Actions (CAPAs) across the CMO network to ensure compliance with global quality standards (GMPs) and regulatory Health Authorities
• Approved batch related documentation (Master batch records – MBRs, Stability Protocols and reports, Process Validation documents, Analytical Protocols and reports, product specifications)
• Responsible for technical batch release, ensuring that all batches meet quality specifications before further manufacture
• Monitor and track Key Performance Indicators (KPIs) / Quality Indicators to evaluate CMO performance, ensuring inspection readiness and operational excellence
• Take action to improve indicators, as necessary
• Established and maintained Quality Agreements with CMOs to ensure compliance and Operational excellence
• Provided onboarding training and coaching to new incoming team members
• Support regulatory submissions to EMA, PDMA, and NMPA, and develop quality risk management plans to identify and mitigate potential risks as part of the QMS system
• Applied risk-based quality oversight strategies to drive continuous improvement and reduce deviations within the external network
• APR (annual product review) / PQR approval
• Author and review of SOPs (standard operating procedures)
• Coach and mentor and motivate new team members
• Influenced decision-making, resolved conflicts and guide cross functional teams (both internal and external) towards achieving project goals
• Achievements: Ensured uninterrupted product supply for DP manufacture Adcetris and Antibody manufacture of Tivdak, as well as clinical supply for SGN-B7H4V, SGN-ALPV, SGN-PDL1V, and SGN-35T
• Led initiatives to enhance CMO KPIs, resulting in a 90% reduction in deviations and notable improvements in CMO performance metrics and CMO relationship
• Awarded for Compliance, Integrity, and Company Value

Responsible for CMO Quality oversight involved of Drug Product (DP) filling (parenterals – sterile manufacture of injectables) for key therapies (Spinraza, BII809B2, BII8093)

• Responsible for Quality oversight of Finished goods (FG) for Tysabri (prefilled syringes)
• Led end-to-end quality oversight for both commercial and clinical products
• This included directing complex investigations, implementing change controls, and overseeing Corrective and Preventive Actions (CAPAs) across the CMO network to ensure compliance with FDA, EMA, and global quality standards (GMPs)
• Provided Quality oversight for Technology transfer, analytical tech transfer and process validation activities
• Monitored and tracked Key Performance Indicators (KPIs) to evaluate CMO performance, ensuring inspection readiness and operational excellence
• Established and maintained Quality Agreements with CMOs to guarantee compliance and timely delivery of GMP documentation
• Supported regulatory submissions and developed quality risk management plans to identify and mitigate potential risks
• Approved batch related documentation for clinical, PPQ and commercial phases
• Achievements: Ensured uninterrupted product supply for DP manufacture of Spinraza, maintaining consistent availability for patients
• Recognized with the CEO Award for effective management of clinical supply, highlighting agility and customer focus in enhancing company operations

• Ensured high standards of quality and compliance within clinical trial processes through extensive collaboration with cross-functional teams
• Developed and implemented quality management plans aligned with Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) standards across various assets
• Leader Auditor for sponsor audits and regulatory inspections, maintaining audit readiness and managing corrective actions (CAPAs) activities to swiftly address any issues
• Lead auditor for Supplier qualification
• Conducted thorough quality assessments and risk analyses, utilizing data to identify and escalate potential quality concerns
• Primary contact for clinical teams on quality-related inquiries, providing GMP guidance and facilitating effective communication among stakeholders

• Responsible for quality oversight in the production suites
• Supervised critical manufacturing activities on a large molecule (DS) manufacturing facility
• Part of Inspection readiness team, supporting regulatory inspections and client audits (back and front office), including PAI for FDA, EMA, ANVISA, and Turkish authorities, and performed internal audits
• Led revision of several GMP documentation (Analytical protocols, stability reports, change controls, and Executed batch records EBRs)
• Managed deviations and critical operations and supported all phases of manufacturing batch documentation development

• Led development of cleaning validation policy and protocols for multipurpose FDA-approved API facility (antibiotic synthesis) and structured equipment and residual validation matrices
• Conducted risk assessments using FMEA for cleaning validation to identify and mitigate potential risks
• Cleaning Validation SME supporting Client audits

• Support the Qualified Person (QP) with batch disposition
• Ensuring timely review of batch records by production and QA for an oral solid dosage form manufacturing facility
• Conducted in-house training for new employees on batch record review
• Escalated potential issues that could affect production, quality, or compliance, and took a proactive approach to resolving these issues
• Reported deviations and out-of-specifications to the Quality Control Manager and identified improvement opportunities within or outside the department

• Responsible for patient counseling and dispensing prescription medicines, OTCs, and other health products
• Processed prescriptions and handled billing
• Determined patient biochemical and physiological parameters and prepared extemporaneous medications
• Arranged medication delivery upon customer request and supported pharmacy marketing campaigns
• Managed the reception of incoming orders