Razvan J.
Global Quality Leader | External Manufacturing & Supplier Quality | GxP Audits | Data Integrity | CSV/CSA | Inspection Readiness | Pharma, Biopharma & MedTech | California
- Role
- Global Quality Audit Program Manager at Bausch + Lomb
- Location
- Los Angeles, CA, US
- LinkedIn followers
- 500 followers
About Razvan J.
Global quality and compliance leader with 16 years of experience across pharmaceutical and medical device manufacturing environments, specializing in global GxP audit programs, inspection readiness, and data integrity governance across internal operations and external manufacturing networks.I currently lead the global corporate GxP audit program for internal manufacturing sites and global functions, with a specialty in data integrity and computerized systems assurance (CSV/CSA). My work includes risk-based audit planning, execution of high-risk audits, CAPA adequacy evaluation, and verification of remediation effectiveness aligned with global regulatory expectations.In addition to internal audit leadership, I support quality oversight across external manufacturing networks, including CMOs/CDMOs and critical suppliers, contributing to risk identification, remediation planning, and inspection readiness activities.I have conducted 180+ GxP audits across North America, EMEA, APAC, and South America across manufacturing sites, distribution operations, and above-site functions.My work frequently focuses on complex compliance areas such as:• Data integrity (ALCOA++, audit trail review expectations, records lifecycle governance)• Computerized systems assurance and validation (Part 11 / Annex 11 environments)• Sterile and aseptic manufacturing environments under EU GMP Annex 1• Risk-based audit strategy aligned with ICH Q9 quality risk management principles• Inspection readiness for FDA, EMA, and Notified Body oversightRegulatory frameworks include EU GMP, US 21 CFR 210/211, and 21 CFR 600–680, as well as ISO 13485 and EU MDR.Credentials include IRCA/CQI Lead Auditor certification, Qualified Person (QP) for EU batch release, and forensic data integrity investigator certification.Target rolesDirector / Associate Director – Global GxP AuditsDirector – Supplier Quality / External Manufacturing QualityDirector – Inspection ReadinessSenior Manager – Global GxP AuditsSenior Manager – Supplier Quality / External Manufacturing QualitySenior – Inspection ReadinessDirector – Quality ComplianceSenior Manager – Quality ComplianceUS permanent resident – no sponsorship required.
Experience
Global Quality Audit Program Manager
Apr 2024 — Present · Los Angeles, CA, US
Lead the global corporate GxP audit program covering internal manufacturing sites and global functions, with a specialty in data integrity and computerized systems assurance.Responsibilities include defining risk-based audit coverage, leading high-risk audits, and ensuring CAPA responses and remediation actions are inspection-defensible across regulated environments.Key contributions include:• Lead global corporate audit program strategy and annual audit plan, including risk-based coverage model, audit scheduling, and resourcing across multiple regions.• Conduct and support high-risk audits of manufacturing operations, laboratories, distribution networks, and enterprise quality systems, with emphasis on complex compliance areas such as data integrity and computerized systems.• Support quality oversight across external manufacturing networks, including CMOs/CDMOs and critical suppliers, through supplier audits and risk-based compliance assessments.• Drive inspection readiness by identifying systemic risks, supporting remediation strategies, and verifying CAPA implementation and effectiveness.• Act as subject matter expert for data integrity and computerized systems assurance, advising sites on audit trail review expectations, governance controls, and sustainable remediation approaches.• Evaluate CSV/CSA evidence for GxP systems used in manufacturing and laboratories (including eQMS, ERP, LIMS, CDS) aligned with Part 11 and Annex 11 expectations.• Partner with manufacturing, quality, IT, engineering, and supply chain leadership to resolve compliance gaps and reduce repeat observations.
Education
Northeastern University
Data Integrity Inspector (in collaboration with Live Oak)
2024 — 2024
University of Academic Economic Studies from Bucharest, International Management and Marketing Master Program
International Management and Marketing Master Program
University of Medicine and Pharmacy Carol Davila, Bucharest
Master of Science (M.S.) - Pharmacist, Pharmacy
Green Mountain Quality Assurance
Data Integrity
2020 — 2020
UCL
Qualified Person for Batch Release
Parenteral Drug Association
Fundamentals of Aseptic Processing
NSF Health Sciences, Miami, Florida
Effective Audits and Self-Inspections, GxP Audits
2014 — 2014
Live OAK
Data Analytics & Quality Intelligence
2024 — 2024
Health Media International, Bucharest, Romania
Applied ICH/GCP Training for Clinical Research Trials; How to Write a Clinical Study Protocol, Good Clinical Practice
2014 — 2014
International Training Centre for Business Administration, Bucharest
Project Management
2012 — 2012
GLC Europe
Pharmacovigilance Audits and Inspections
2021 — 2021
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