Global M&S Services, Manager Quality Services - Third Party Audits, Budapest Hub
Core
Manage supplier audits and ensure compliance with cGMPs and regulations for third-party manufacturers and contract organizations in the pharmaceutical industry.
Role type
Manager, Quality Services (Third Party Audits)
Builds
Quality assurance and compliance for outsourced manufacturing partners
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
client delivery
Required skills
cGMP knowledge, regulatory compliance (CFR), CAPA systems, on-site audit execution, supplier quality assessment, GMP requirements
Preferred skills
Managing third-party manufacturers, contract manufacturer organization experience, manufacturing site operations
Technologies
GxP, CAPA systems
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, hands-on IC
