VP Head Corporate Quality

vor 4 Wochen

Zürich, Schweiz Skillhubs Vollzeit

Responsibilities:

  • Represent Quality Assurance in cross-functional clinical development program teams and meetings with CDMOs, CROs, CTLs, and other service providers.
  • Develop and communicate a comprehensive vision for quality within the company.
  • Lead the Quality Assurance department, overseeing all quality functions including product development, distribution, supplier management, and contract manufacturing.
  • Establish and maintain an effective Quality Management System (QMS), ensuring adherence to FDA regulatory requirements, ICH guidelines, and industry standards.
  • Drive the development and implementation of strategies to enhance quality performance and mitigate risks.
  • Manage regulatory agency interactions, including preparation for and response to FDA inspections.
  • Lead recall procedures and oversee the execution and communication of field alerts and recalls.
  • Provide strategic direction for timely and complete responses to quality-related regulatory queries.
  • Collaborate cross-functionally to ensure alignment with company objectives and goals.
  • Oversee staff training, development, performance management, and recruitment within the Quality Assurance department.
  • Monitor key quality metrics, analyze insights, and report findings to senior management during management reviews.
  • Manage the quality department budget to support company objectives effectively.

Profile:

  • Minimum of 15 years of experience in the pharmaceutical/biotechnology sector, with at least 10 years in a leadership role within Quality Assurance.
  • Expert knowledge of FDA regulatory requirements, ICH guidelines, and industry standards.
  • Proven track record in successfully managing inspection readiness programs and regulatory inspections.
  • Strong leadership skills with the ability to influence and effect change within the organization.
  • Excellent communication and collaboration skills, with the ability to build strong working relationships cross-functionally.
  • Demonstrated ability to drive results and improve business performance.
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