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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Vendor and Third-Party Management, Quality Assurance, and Compliance within clinical research and Medical Affairs. Proficient in regulatory requirements, quality management systems, and effective oversight of third-party relationships.
Highest-signal resume keywords
Vendor & Third-Party ManagementQuality AssuranceClinical Trial ExperienceRegulatory ComplianceQuality Management Systems
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality Event ManagementCAPA ManagementGxP RequirementsRisk ManagementClinical Data Systems IntegrationAudit ProcessesStudy ManagementRegulatory RequirementsThird-Party Due DiligencePharmaceutical Product Development
Soft Skills
Problem-SolvingNegotiationConflict ResolutionDetail-OrientedMulti-Tasking
Tools & Technologies
TPMATClinical Data SystemsQuality Management Systems
Industry Keywords
Clinical ResearchMedical AffairsCROFDA RequirementsEMA RequirementsICH RegulationsGCP/GVP Requirements
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Manage Quality Events, Quality Issues, deviations, and related investigations with relevant stakeholders
- Act as Deviation Owner and support CAPA definition, implementation, tracking, effectiveness assessment, and closure
- Support internal and external audits, audit readiness activities, and remediation of audit findings
- Ensure quality records, supporting documentation, and evidence are complete, accurate, traceable, and inspection ready
- Support third-party governance and oversight from a quality and compliance perspective
- Contribute to third-party Quality Risk Assessments for GMA activities, including NIS, RWE/RWD activities, Research Collaborations, and partnerships
- Follow up on identified risks and mitigation actions
- Identify, assess, and escalate potential risks from third-party due diligence, qualification, and oversight activities
- Ensure compliance with SOPs, business guidance documents, quality standards, and regulatory requirements
- Support Research Collaboration and selected non-vendor third-party due diligence and assessment activities
- Coordinate with internal stakeholders and third parties to obtain due diligence and assessment documentation
- Maintain and continuously improve TPM due diligence tools, including TPIAT
- Lead or contribute as a subject matter expert to the design, revision, implementation, and improvement of GMA V&TPM quality, compliance, governance processes, standards, procedures, and guidance
- Provide V&TPM quality and compliance expertise, guidance, and training to operational teams and stakeholders
- Collaborate with ESP Quality Assurance, Medical QA, GMA Medical Governance & Risk Management, Procurement, VPG, and other stakeholders to ensure effective third-party oversight
Requirements
What you’ll need- Degree in a life science or healthcare-related discipline
- Previous experience in Vendor & Third-Party Management, Quality Assurance, Compliance, or a similar role supporting clinical research or Medical Affairs activities
- Clinical Trial/Medical Affairs experience in a pharmaceutical company or a Contract Research Organization (CRO) is required
- Experience working with external suppliers, research partners, and cross-functional stakeholders within a pharmaceutical company or CRO environment
- Excellent understanding of study management
- Strong understanding of clinical and Medical Affairs processes, study management activities, and associated external services
- Good knowledge of regulatory requirements in Clinical Research and drug development
- In-depth knowledge of the international pharmaceutical product development process
- Experience with GxP requirements, quality management systems including risk management, and regulatory requirements from main Health Authorities
- Broad understanding of FDA and EMA requirements, as well as ICH regulations and guidelines
- Strong understanding 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, including CROs, Central Labs, specialty services, eCOA, and new technologies
- Experience and ability to manage/supervise third parties and external suppliers
- Good understanding of clinical data systems/platforms and integration of clinical data systems and processes
- Fluent written and spoken English
- Strong problem-solving, negotiation, and conflict resolution skills
- Diligent, detail-oriented, accurate, accountable, multi-tasking, service-oriented, and good with numbers
Benefits
Comp & perks- Incentive plans, bonuses, and/or other forms of compensation may be offered
- Health and welfare benefits may be offered
- Other benefits may be offered