Quality Assurance and Compliance Specialist
19 hours ago
The Vendor Qualification Specialist is responsible for overseeing the qualification and management of vendors that support GxP systems and services. This role ensures that vendors are selected, assessed, and managed in accordance with applicable regulatory requirements, industry standards, and internal quality processes.
ResponsibilitiesVendor Oversight & Assessment- Lead and execute vendor qualification activities for third-party providers such as software as a service SaaS, integrated research technology IRT, electronic trial master file eTMF, contract research organizations CROs, and IT service providers.
- Develop and maintain the vendor qualification strategy and risk-based assessment framework to ensure compliance throughout the product lifecycle.
- Conduct vendor audits remote and on-site, prepare audit plans, reports, and corrective actions follow-up to identify areas for improvement.
- Maintain up-to-date documentation for vendor qualification including risk assessments, questionnaires, and technical agreements.
- Establish and maintain a centralized vendor inventory and qualification status to facilitate collaboration with cross-functional teams.
- Collaborate with procurement, IT, validation, and business owners to ensure vendor compliance throughout the lifecycle.
- Ensure appropriate contracts, quality technical agreements QTAs, and service level agreements SLAs are in place to manage vendor relationships.
- Participate in vendor onboarding and change control processes for qualified vendors to ensure seamless integration.
- Stay abreast of evolving regulatory expectations for third-party oversight and ensure adherence to industry standards.
- Support inspection readiness and represent vendor oversight during audits or regulatory inspections to maintain credibility.
- Identify areas for improvement in vendor management processes and drive continuous improvement to enhance efficiency.
- Provide training and guidance on vendor qualification procedures across functions to promote standardization.
- Bachelor's or Master's degree in life sciences, computer science, quality, or a related field to possess a strong foundation in scientific principles and methodologies.
- Minimum 5-8 years of experience in QA, compliance, or validation roles in the life sciences industry to develop expertise in regulatory requirements and quality management.
- 3+ years of direct experience in vendor qualification or third-party oversight for GxP systems to demonstrate proficiency in vendor management.
- Experience conducting vendor audits and managing supplier corrective actions CAPAs to identify and resolve issues efficiently.
- In-depth understanding of software development lifecycles and cloud vendor qualification to ensure compatibility with modern technologies.
- Strong analytical, communication, and negotiation skills to collaborate effectively with stakeholders.
- Ability to manage multiple priorities in a fast-paced environment to meet deadlines and deliver results.
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