Associate Director, Good Clinical Practice (GCP) Audit and Vendor Management(m/w/x)

Beschreibung

You will lead the strategy and execution of GCP audits and vendor oversight to ensure clinical trial integrity. By leveraging Veeva Vault, you'll manage high-level compliance and drive quality across research partnerships.

Anforderungen

• •Degree in Life Sciences, Pharmacy, Business, or related field
• •Experience in vendor management, clinical operations, GCP auditing, or quality assurance
• •Knowledge of GCP, ICH guidelines, and global regulatory requirements
• •Experience in GCP compliance, audit readiness, and vendor performance management
• •Experience with Veeva Vault for quality management and vendor oversight
• •Excellent leadership, communication, analytical, and problem-solving skills
• •Ability to manage multiple projects and stakeholders
• •Interaction with all levels of the organization
• •Proficiency in relevant vendor management systems
• •PC literacy and MS Office skills
• •Certification in GCP auditing or clinical research
• •Experience with eTMF and CTMS
• •Familiarity with risk-based quality management principles
• •Experience in Veeva Vault Quality Suite implementation
• •Flexibility to travel internationally
• •Willingness to travel up to 35%
• •Ability to perform overnight on-site audits

Aufgaben

• •Operationalize approved GCP audit plans and strategies
• •Coordinate audit schedules and resources with stakeholders
• •Review documentation and quality systems before audits
• •Perform on-site and remote routine or for-cause audits
• •Evaluate compliance with GCP regulations and guidelines
• •Document audit findings, deviations, and non-compliance
• •Interview personnel and gather evidence during audits
• •Prepare comprehensive audit reports and recommendations
• •Ensure timely completion of reports and CAPAs
• •Develop robust audit strategies for clinical trial vendors
• •Lead vendor audits to identify and resolve gaps
• •Maintain inspection readiness for vendor-related activities
• •Act as GCP subject matter expert for compliance
• •Manage audit findings and documentation in Veeva Vault
• •Develop a comprehensive GCP vendor management strategy
• •Lead the selection and qualification of clinical vendors
• •Establish and maintain strong vendor relationships
• •Track vendor onboarding and performance via Veeva Vault
• •Oversee contract negotiations, SLAs, and KPIs
• •Maintain documentation for qualifications and compliance
• •Develop performance metrics and vendor scorecards
• •Conduct regular vendor quality assessments
• •Resolve performance issues and non-compliance incidents
• •Serve as the primary escalation point for vendors
• •Partner with cross-functional clinical and regulatory teams
• •Lead vendor governance meetings and performance reviews
• •Train teams on Veeva Vault for vendor oversight
• •Identify and mitigate risks in vendor partnerships
• •Drive process improvements for GCP compliance
• •Stay updated on regulatory changes and best practices
• •Optimize Veeva Vault solutions for management efficiency
• •Coach and mentor junior auditors and new staff

Tools & Technologien