Job Summary The Vendor Qualification Manager is responsible for overseeing the qualification monitoring and ongoing assessment of vendors that support GxP systems and services This role ensures that vendors are selected assessed and managed in accordance with applicable regulatory requirements FDA EMA MHRA GAMP 5 principles and internal quality standards Key Responsibilities Vendor Qualification AssessmentLead and execute vendor qualification activities for GxP-relevant third-party providers e g SaaS IRT eTMF CROs IT service providers Develop and maintain the vendor qualification strategy and risk-based assessment framework Conduct vendor audits remote and on-site prepare audit plans reports and CAPA follow-up Maintain up-to-date documentation for vendor qualification including risk assessments questionnaires and technical agreements Governance Lifecycle OversightEstablish and maintain a centralized vendor inventory and qualification status Collaborate with Procurement IT Validation and Business Owners to ensure vendor compliance throughout lifecycle Ensure appropriate contracts Quality Technical Agreements QTAs and SLAs are in place Participate in vendor onboarding and change control processes for qualified vendors Compliance Continuous ImprovementStay abreast of evolving regulatory expectations for third-party oversight Support inspection readiness and represent vendor oversight during audits or regulatory inspections Identify areas for improvement in vendor management processes and drive continuous improvement Provide training and guidance on vendor qualification procedures across functions Qualifications EducationBachelor s or Master s degree in Life Sciences Computer Science Quality or a related field ExperienceMinimum 5-8 years of experience in QA compliance or validation roles in the life sciences industry 3 years of direct experience in vendor qualification or third-party oversight for GxP systems Experience conducting vendor audits and managing supplier CAPAs Strong knowledge of GxP regulations 21 CFR Part 11 EU Annex 11 GAMP 5 and ICH Q10 SkillsIn-depth understanding of software development lifecycles and cloud vendor qualification e g SaaS Strong analytical communication and negotiation skills Ability to manage multiple priorities in a fast-paced workplace Proficiency in quality systems and tools e g eQMS VMS audit tracking tools Preferred QualificationsAuditor certification e g ISO 9001 ISO 27001 or equivalent Knowledge of data integrity principles and AI ML vendor oversight Familiarity with privacy requirements GDPR HIPAA for vendor assessment Working ConditionsSome travel required 15-25 for on-site vendor audits May require flexible hours to work with global teams

📌 Manager, Quality Trust And Compliance (vendor Qualification) (Karnataka)
🏢 Important Company of the Sector
📍 Karnataka