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Director, Quality Assurance Compliance

alcon · Texas

Senior 🇬🇧 English
ISO standards Supplier quality management

Job description

About the role

Alcon is seeking a Director of Quality Assurance Compliance to lead Quality Systems, Complaints, and Supplier Quality Management at its Houston manufacturing site. The role ensures compliance with cGMP, health authority regulations, the Alcon Quality Manual and ISO standards while driving continuous improvement.

Key responsibilities

  • Lead and develop cross‑functional teams to achieve quality objectives aligned with corporate goals.
  • Manage Quality Systems including internal/external audits, document control, change control and training.
  • Oversee complaints handling and supplier quality activities, including risk assessments, audits and non‑conformance investigations.
  • Implement the Quality Strategy, identify process‑efficiency opportunities and drive corrective actions.
  • Prepare for and participate in external audits by notified bodies and health authorities.
  • Control departmental budgets, allocate resources and approve major projects.

Required profile

  • Proven leadership experience in quality assurance within a regulated manufacturing environment.
  • Strong knowledge of current Good Manufacturing Practices (cGMP) and ISO quality standards.
  • Demonstrated ability to manage audits, supplier quality programs and regulatory compliance.
  • Excellent strategic planning, problem‑solving and communication skills.

Required skills

  • cGMP compliance
  • ISO standards (e.g., ISO 9001)
  • Document control systems
  • Change control processes
  • Supplier quality management
  • Audit preparation and execution
  • Risk assessment and mitigation

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Source : ats:workday

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Published 4 months ago

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alcon

Texas