Global M&S Services, Manager Quality Services - Third Party Audits, Budapest Hub
Core
Manage quality compliance and conduct audits for third-party manufacturers and contract organizations to ensure product safety and regulatory adherence.
Role type
Manager, Quality Services (Third Party Audits)
Builds
Quality assurance and compliance for pharmaceutical manufacturing partners
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (Quality Audits & Compliance)
Required skills
cGMP knowledge, CAPA management, GMP requirements, on-site audit execution, regulatory inspection handling, supplier quality assessment, risk-based decision-making
Preferred skills
Managing third-party manufacturers, working on manufacturing sites
Technologies
GxP, Code of Federal Regulations (drugs and biologics)
Responsibilities
Conduct on-site and remote audits of GxP and health-regulated third-party vendors, ensure compliance with corporate QA policies and country-specific regulations, identify and resolve quality gaps in product design and manufacturing, track market developments and regulatory changes, follow up on CAPAs, interface with specialists and local quality contacts.
Seniority
Manager, 7-10 years industry experience
