Manager, Quality Trust and Compliance (Vendor Qualification)

Job Summary

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