VALERIO WILLIAM VALERI
Visp
Overview
17
17
years of professional experience
Work History
Associate Director, Head Quality Service Oversight
Lonza
Visp
01.2023 - Current
- Define and implement the oversight framework and governance for services delivered by the shareholders.
- Ensuring shareholder compliance with Quality Service Agreements (QSAs).
- Supporting BioAtrium departments on matters related to shareholder services.
- Authoring and maintaining contractual agreements with the shareholders.
- Driving continuous improvement and updates of QSAs based on evolving business needs.
- Managing and following up on service-related issues raised by internal departments.
- Acting as Subject Matter Expert (SME) on oversight of shareholder services.
- Defining, collecting, and presenting KPIs concerning services to the Leadership Team.
- Overseeing raw material quality, including qualification and release.
- Leading supplier qualification processes for raw materials.
- Serving as lead auditor for qualifying shareholders as service providers
- BioAtrium is a joint venture between Lonza and Sanofi, operating as an independent legal entity with its own Leadership Team and Board of Directors. Its purpose is to provide both shareholders—and their customers—access to new large‑scale biologics manufacturing capacity. BioAtrium operates the plant under a proprietary manufacturing license while relying on services delivered by its shareholders.
Quality System Manager
Lonza
Visp
08.2019 - 12.2022
- Establish and maintain the supplier qualification process
- Manage qualification of suppliers and service providers; act as the single point of contact (SPOC) with stakeholders
- Ensure BioAtrium quality requirements are covered in quality agreements with service providers
- Define, implement, and report service providers performance metrics (KPIs) and related compliance topics
- Manage supplier change notifications and quality alerts
- Review and co‑approve specifications, sampling procedures, QC plans, reference documents, change requests, and deviations related to raw materials and suppliers
- Support inspection readiness activities for regulatory inspections and customer audits
- Serve as SME for supplier management during audits/inspections, contribute to responses, and define appropriate CAPAs
- Act as auditor during qualification of services provided by shareholders
ESO (External Supplier Operations) QA Compliance Manager
Novartis
Basel
09.2017 - 07.2019
- Drive the global development, implementation, and continuous improvement of ESO processes to support QA oversight of suppliers, including supplier approval, high‑risk supplier management, quality oversight levels, and associated KQIs.
- Serve as the primary interface between ESO QA Systems Compliance Oversight (SCO), global supplier‑managing entities, and cross‑functional stakeholders (e.g., Technical Operations, Material Supply, Development, Commercial Operations) to ensure consistent quality standards and guidance.
- Contribute to the ESO transformation program by streamlining and harmonizing ESO processes, including drafting SOPs, work instructions, QAA templates, and annexes.
- Support and coordinate supplier‑related activities across sub‑platforms for all ESO and NTO processes, such as escalations and high‑risk supplier management.
- Participate in ESO sub‑platform Quality Committee meetings, provide compliance reporting, and track KQIs against targets defined in the Quality Plan and target letter, aligned with NTO ESO QA strategy.
- Act as a Compliance SME during internal audits, support sub‑platforms and sites in drafting responses to health authority findings involving ESO suppliers, and prepare and conduct/support internal audit
Quality Assurance Manager, GMP Compliance & Auditing
Dynavax GmbH
Dusseldorf
01.2016 - 08.2017
- Manage site inspection readiness; define processes and logistics with site leadership; coordinate front/back office; prepare inspection statistics; support communication of responses to authorities.
- Represent Compliance during Health Authority inspections (including FDA).
- Communicate responses to inspection findings to Health Authorities and ensure timely closure of regulatory commitments.
- Serve as internal/external certified Lead Auditor.
- Define and manage a risk‑based auditing program; coordinate and perform internal/external audits; follow up on CAPA plans.
- Lead continuous improvement projects related to Quality Assurance (e.g., data integrity remediation initiatives).
- Ensure Site Master File (SMF) compliance; maintain updates and author content for submissions to local authorities.
- Lead and manage a team of three people
Quality Audit Specialist
GSK Vaccines
Siena
05.2014 - 12.2015
- Plan, execute, and support internal audits to ensure compliance with regulatory, industry, and company standards.
- Organize and support preparations for regulatory, third‑party, and internal inspections (e.g., AIFA, FDA, ANVISA, MFDS), including hosting activities, coordinating responses to findings, and following CAPA implementation.
- Perform gap assessments, including review of past inspection near‑misses and benchmarking Health Authority observations from other sites to prevent recurrence.
- Review and approve SOPs and technical reports to ensure compliance and quality standards.
- Ensure timely completion of deviations and CAPAs, acting as owner‑investigator when assigned.
- Monitor, track, and report CAPA commitments, including metrics management for Compliance Unit.
- Follow up on remediation activities arising from Site Quality Risk Assessments (SQRA).
- Contribute to Annual Product Reviews (APR) by providing compliance‑related product information
Commissioning and Qualification Specialist
SGS Sertec
Livorno
01.2013 - 04.2014
- Execute qualification and validation activities of new sterile production lines
- Perform validation of laboratory computerized systems and Building Management System (BMS) according to US 21 CFR Part 11, EU GMP Annex 11 requirements
- Validation for controlled contamination areas (leak test, smoke testing) Physical and biological validation of Sterilization in place SIP and cleaning in place CIP equipment
Computer System Validation Specialist
Pharma Quality Europe
Figline Valdarno, Florence
01.2011 - 12.2012
- Draft Validation Plans, User Requirements, Traceability Matrix, Installation, Operational (IOQ) and Performance Qualification (PQ) related to validation of laboratory equipment and Process Control System
- Execution of validation test protocols IQ, OQ, PQ
- Perform computerized system gap analysis based on US 21 CFR Part 11, EU GMP Annex 11 requirements and GAMP5 guidelines
Quality Control Specialist
Silo S.p.a.
Florence
10.2009 - 12.2010
- Perform microbiological testing on raw material, LAL test, bioburden determination
- Umidity content (Karl Fischer Titration method)
- Purity assessment by HPLC / MS
Education
Doctorate (Ph.D.) - Oncology and Molecular Endocrinology
University of Naples Federico II
Napoli, Italy10.2009
Master (Laurea) - Biological Science
Università degli Studi di Firenze
Italy09.2004
Custom Section
+41.78.401.5719
Languages
English, Italian
First Language
French
Intermediate
B1
Interests
Running, mountain biking,
Timeline
Associate Director, Head Quality Service Oversight
Lonza
01.2023 - Current
Quality System Manager
Lonza
08.2019 - 12.2022
ESO (External Supplier Operations) QA Compliance Manager
Novartis
09.2017 - 07.2019
Quality Assurance Manager, GMP Compliance & Auditing
Dynavax GmbH
01.2016 - 08.2017
Quality Audit Specialist
GSK Vaccines
05.2014 - 12.2015
Commissioning and Qualification Specialist
SGS Sertec
01.2013 - 04.2014
Computer System Validation Specialist
Pharma Quality Europe
01.2011 - 12.2012
Quality Control Specialist
Silo S.p.a.
10.2009 - 12.2010
Doctorate (Ph.D.) - Oncology and Molecular Endocrinology
University of Naples Federico II
Master (Laurea) - Biological Science
Università degli Studi di Firenze