R&D Quality Inspection Management Leader

1 day ago

Cambridge, Cambridgeshire, United Kingdom Gilead Sciences Full time

About the Role

We are seeking a highly skilled R&D Quality Inspection Management Leader to join our team at Gilead Sciences. This role will be responsible for managing and executing R&D inspection activities, ensuring compliance with regulations and maintaining a culture of quality within the organization.

Key Responsibilities

  • Develop and implement comprehensive inspection management frameworks to ensure readiness, preparation, conduct, and close-out of inspections
  • Serve as business process owner of inspection management in R&D, leading operational, managerial, and administrative activities
  • Support global R&D inspection readiness by advising on Gilead practices, procedures, systems, and tools
  • Collaborate cross-functionally to gather and analyze risks, establish mitigations, and support remediation
  • Develop and deliver inspection-specific GxP training for the R&D organization
  • Build relationships and a network of cross-functional stakeholders to promote and enhance inspection readiness
  • Contribute to the generation and continuous improvement of Gilead R&D inspection preparation tools
  • Provide a framework to ensure training of Gilead R&D personnel on dossier collation and requirements pre-regulatory agency inspections
  • Prepare and lead instructor-led training of Gilead R&D personnel in preparation for regulatory agency inspections

About You

  • Bachelor's degree in life sciences or related field with significant relevant experience in the biopharma industry, including quality, compliance, or a related field
  • Significant experience advising business functions in the biopharma industry on quality and compliance requirements, evolving regulations, risk minimization, and mitigation, and continuous improvement
  • Significant experience in inspection management in the biopharma industry
  • Proven track record of effective people leadership and management, employee engagement, development, and retention either with direct reports or through matrix leadership responsibilities
  • Line management (direct reports) experience preferred
  • Track record of cultivating and maintaining strategic relationships and collaborations both internally and externally
  • Experience participating or leading external consortiums, trade associations, professional bodies, or industry groups
  • Proven track record of successfully managing large-scale, complex, time-sensitive projects
  • Hands-on experience leading cross-functional process improvement initiatives with measurable outcomes

Salary Range:$140,000 - $170,000 per annum

This is an excellent opportunity to join a dynamic team and make a meaningful impact in the biopharma industry. If you are a motivated and experienced professional with a passion for quality and compliance, we encourage you to apply for this role.

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