Vendor & Third-Party Management Quality and Compliance Manager

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

📋 Description

• Oversee Quality Events, Quality Issues, deviations, and associated investigations in collaboration with relevant stakeholders.

• Serve as the Deviation Owner and assist in the definition, implementation, tracking, effectiveness assessment, and resolution of CAPA.

• Aid in internal and external audits, as well as audit readiness activities and the remediation of audit findings.

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

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

• Participate in third-party Quality Risk Assessments for GMA activities, which include non-interventional studies, real-world evidence/data activities, Research Collaborations, and partnerships.

• Follow up on identified risks and the associated mitigation actions.

• Identify, evaluate, and escalate risks related to third-party due diligence, qualification, and oversight.

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

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

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

• Maintain and continually 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.

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

• Work in collaboration 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 comparable role supporting clinical research or Medical Affairs activities.

• Required experience in Clinical Trials/Medical Affairs within a pharmaceutical company or a Contract Research Organization (CRO).

• Familiarity with external suppliers, research partners, and cross-functional stakeholders in a pharmaceutical company or CRO setting.

• Excellent comprehension of study management.

• Strong knowledge of clinical and Medical Affairs processes, study management activities, and related external services.

• Proficient understanding of regulatory requirements concerning Clinical Research and drug development.

• Extensive knowledge of the international pharmaceutical product development process.

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

• Broad understanding of FDA and EMA requirements, as well as ICH regulations and guidelines.

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

• Understanding of procurement processes and the clinical external suppliers landscape, which includes 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 integration of clinical data systems and processes.

• Proficient 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 comfortable with numbers.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career advancement.

• Flexible work arrangements to promote work-life balance.

• A collaborative and innovative work environment.