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Site Quality Director

2 months ago

Richmond, Greater London, United Kingdom Consult Full time
About the Role

Consult is seeking a highly experienced Site Quality Director to oversee the quality management of our pharmaceutical manufacturing facility in the UK.

As a key member of our team, you will be responsible for ensuring compliance with UK, EU, and FDA cGMP standards, and driving continuous quality improvement.

Key Responsibilities
  • Leadership and Team Management: Provide strong leadership to the quality team, fostering a positive and collaborative work environment.
  • Quality Strategy Development: Develop and implement a sustainable quality strategy for the site, aligned with the company's strategic goals.
  • Resource Management: Manage departmental activities and resources within budget and timelines.
  • Performance Improvement: Drive performance improvements and ensure compliance with regulatory requirements.
  • Regulatory Compliance: Coordinate with regulatory authorities and stakeholders.
  • Team Development: Mentor and develop the quality team to improve their knowledge and skills.
  • Initiative Implementation: Support the implementation of new initiatives and systems.
  • Communication: Establish effective communication strategies.
  • Troubleshooting: Troubleshoot and contribute to manufacturing and testing issues.
  • Reporting: Report on changes in standards and performance.
  • Audit Management: Host regulatory and customer audits.
  • Inter-Site Collaboration: Liaise with the multi-site Quality Director to ensure consistency across manufacturing sites.
About You

The ideal candidate will have:

  • Significant Leadership Experience: Significant leadership experience in a pharmaceutical quality environment.
  • Pharmaceutical Quality Expertise: Extensive experience in pharmaceutical quality, including audit, batch record review, change control, complaint handling, and investigations.
  • Time Management: Ability to prioritise work and handle multiple deadlines.
  • Regulatory Knowledge: A thorough understanding of pharmaceutical manufacturing, packaging, testing, and distribution processes, as well as global regulatory requirements.
  • Inspection Experience: Experience with UK and FDA inspections, client audits, and self-inspections.
  • Quality System Implementation: Proven track record of implementing and maintaining quality systems.
  • Technical Knowledge: Technical knowledge to support quality and validation decision making.
  • Project Management: Experience working on multi-department projects.
  • QP Eligibility: Eligibility for QP status is highly desirable.
  • Travel Requirements: Occasional global travel may be required.

Please note, this is a fully site-based position.