Hybrid Global C&Q Director

Posted last week

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About the role

  • Lead and manage the consistent deployment of best in class capability and capacity of commissioning and qualification activities
  • Ensure all project equipment, systems, and processes consistently meet regulatory and company standards
  • Collaborate with cross-functional teams including engineering, quality assurance, manufacturing, and regulatory affairs
  • Drive towards best in class practices leveraging digital and AI
  • Support development and implement global C&Q strategies and policies
  • Provide leadership and direction to regional/project C&Q teams
  • Oversee the planning, execution, and completion of C&Q projects across multiple projects
  • Provide technical guidance and support for C&Q activities
  • Ensure compliance with GSK’s quality management system and applicable regulatory requirements
  • Support recruitment, training, and mentoring of C&Q staff
  • Build and maintain strong relationships with internal and external stakeholders

Requirements

  • Engineering degree (Mechanical, Electrical, Chemical, Civil/Structural)
  • Extensive project validation experience
  • Proven experience in leading validation teams in the pharmaceutical or biotech industry
  • Proven track record of successfully leading and managing global C&Q projects
  • Proven track record of regulatory authority audit participation and defence of validation project plans and results
  • In-depth knowledge of regulatory requirements and industry standards (e.g., GMP, GAMP, ICH guidelines)
  • Experience in biopharm specific unit operations and platforms – drug substance/primary, DP/sterile filling, and packaging
  • Strong project management skills, with experience in managing complex, multi-site projects
  • Deep and broad understanding of the capital project lifecycle – design, construction, commissioning, qualification, to operation.
  • Strong stakeholder management and influencing capabilities

Benefits

  • Health insurance
  • 401(k) matching
  • Flexible working hours
  • Paid time off
  • Professional development opportunities

Job title

Global C&Q Director

Job type

Experience level

Lead

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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