Manager, Quality Trust and Compliance (Vendor Qualification)

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 & Assessment

· Lead 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 Oversight

· Establish 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 Improvement

· Stay 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

Education

· Bachelor’s or Master’s degree in Life Sciences, Computer Science, Quality, or a related field.

Experience

· Minimum 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.

Skills

· In-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 environment.

· Proficiency in quality systems and tools (e.g., eQMS, VMS, audit tracking tools).

Preferred Qualifications

· Auditor 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 Conditions

· Some travel required (~15–25%) for on-site vendor audits

· May require flexible hours to work with global teams