Vendor & Third-Party Management Quality and Compliance Manager

This is a fully remote position, open to applicants in Spain.

📋 Description

• Provide Quality Assurance support for Global Medical Affairs Vendor & Third-Party Management.

• Manage quality events, quality issues, deviations, investigations, and Corrective and Preventive Actions (CAPAs).

• Serve as Deviation Owner when appropriate.

• Assist in the definition, implementation, tracking, effectiveness assessment, and closure of CAPAs.

• Support internal and external audits, audit readiness activities, and the remediation of audit findings.

• Ensure that quality records, supporting documentation, and evidence are complete, accurate, traceable, and ready for inspection.

• Provide governance and oversight for third-party engagements from a quality and compliance standpoint.

• Contribute to third-party Quality Risk Assessments and follow up on identified risks and mitigation strategies.

• Identify, evaluate, and escalate risks associated with third-party due diligence, qualification, and oversight.

• Ensure adherence to SOPs, business guidance documents, quality standards, and regulatory requirements.

• Support Research Collaboration and selected non-vendor third-party due diligence and assessment activities.

• Liaise with internal stakeholders and third parties to gather due diligence information and documentation.

• Maintain and enhance TPM due diligence tools, including TPIAT.

• Lead or contribute as a subject matter expert in the design, revision, implementation, and enhancement of GMA V&TPM quality, compliance, and governance processes, standards, procedures, and guidance.

• Provide V&TPM quality and compliance expertise, guidance, and training.

• Collaborate with ESP Quality Assurance, Medical QA, GMA Medical Governance & Risk Management, Procurement, Vendor & Partner Governance, and other stakeholders.

⛳️ Requirements

• A degree in a life science or healthcare-related field.

• Prior experience in Vendor & Third-Party Management, Quality Assurance, Compliance, or a similar role supporting clinical research or Medical Affairs activities.

• Required clinical trial/medical affairs experience in a pharmaceutical company or a Contract Research Organization (CRO).

• Experience engaging with external suppliers, research partners, and cross-functional stakeholders within a pharmaceutical company or CRO environment.

• Familiarity with clinical/medical affairs processes and activities, along with a comprehensive understanding of study management.

• Strong grasp of clinical and Medical Affairs processes, study management activities, and associated external services.

• Good knowledge of regulatory requirements pertaining to Clinical Research and drug development.

• In-depth understanding of the international pharmaceutical product development process.

• Experience with GxP requirements, quality management systems, including risk management, and regulatory guidelines from major Health Authorities.

• Broad knowledge of key Health Authorities standards, including FDA and EMA requirements, along with ICH regulations and guidelines.

• Solid understanding of Quality Management Systems, GCP/GVP requirements, audit processes, CAPA management, and risk management principles.

• Familiarity with procurement processes and the clinical external supplier landscape, including CROs, Central Labs, specialty services, eCOA, and new technologies.

• Experience and capability to manage/supervise third parties and external suppliers.

• Good understanding of clinical data systems/platforms and the overall integration of clinical data systems and processes.

• Proficiency in written and spoken English.

• Strong problem-solving, negotiation, and conflict resolution abilities.

• Diligent, detail-oriented, accurate, accountable, capable of multi-tasking, service-oriented, and proficient with numbers.

🏝️ Benefits

• Competitive salary.

• Comprehensive benefits package.

• Medical care plan that includes Health, Dental & Vision coverage.

• Life Assurance.

• Exceptional work environment.

• Culture of teamwork and collaboration.

• Access to innovative technology.

• Outstanding training opportunities.