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Audit Leader for Vendor Management

vor 2 Wochen

Basel, Basel-Stadt, Schweiz TN Switzerland Vollzeit

We are seeking a highly skilled Senior Quality Assurance Manager to join our Vendor Management team. As a key member of our team, you will be responsible for ensuring compliance with GCP regulations through effective audit planning and execution.

  • You will develop and implement robust audit plans and strategies for R&D GCP audits, ensuring compliance with relevant regulations and industry standards.
  • Lead on-site or remote audits, evaluating compliance with GCP regulations, internal quality standards, and relevant guidelines.
  • Prepare comprehensive audit reports outlining findings, observations, and recommendations for corrective actions.

Key Responsibilities:

  • GCP Compliance, Audits & Oversight:
  • Please see below

Vendor Strategy & Oversight:

  • Please see below

Contracting & Compliance:

  • Please see below

Collaboration & Stakeholder Management:

  • Please see below

Risk Management & Continuous Improvement:

  • Please see below

Qualifications & Requirements:

  • Bachelor's degree in Life Sciences, Pharmacy, Business, or related field (Master's preferred).
  • 8+ years of experience in vendor management, clinical operations, GCP auditing, or quality assurance within the pharmaceutical, biotechnology, or clinical research industry.
  • Strong knowledge of GCP, ICH guidelines, and global regulatory requirements.
  • Proven experience in GCP compliance, audit readiness, and vendor performance management.
  • Experience with Veeva Vault for quality management, audit tracking, and vendor oversight.
  • Excellent leadership, communication, analytical, and problem-solving skills.
  • Ability to manage multiple projects and stakeholders in a fast-paced environment.