Director, Good Clinical Practices (GCP)

About the role

Director, Good Clinical Practices (GCP) within Alcon’s Quality & Regulatory Affairs function in Fort Worth, TX. The role leads strategic initiatives to ensure adherence to GCP and lifecycle management regulations in the R&D Quality Assurance department, guiding a team to develop and implement quality and regulatory protocols for clinical trials.

Key responsibilities

• Provide leadership and strategic direction to multiple teams to implement departmental plans and achieve business objectives.
• Oversee team performance, resource allocation, and project approvals while fostering a culture of excellence and compliance.
• Drive cross‑functional quality culture and ensure implementation of quality management systems at every stage of processes and operations.
• Make key decisions impacting significant projects and initiatives.
• Implement quality plans throughout the clinical trial process and ensure compliance with quality assurance regulations.
• Support audits, regulatory inspections, and all quality control aspects, reporting issues and leading implementation of new regulations.
• Lead performance management, talent development, and associate relations.

Required profile

• Bachelor’s degree or equivalent experience (e.g., high school + 18 years, Associate + 14 years, M.S. + 7 years, PhD + 6 years).
• Fluent reading, writing, and communication in English.
• At least 10 years of relevant experience.
• Minimum 6 years of demonstrated leadership.
• Willingness to travel up to 20 %.
• On‑site work location in Fort Worth, TX.
• Relocation assistance authorized; no sponsorship assistance.

Required skills

• Good Clinical Practices (GCP) knowledge.
• GXP regulatory expertise.
• Quality Management Systems implementation.