Senior Manager, Quality Assurance Compliance

About the role

The Senior Manager, Quality Assurance Compliance is a key quality leader at Alcon’s Irvine Technology Center. The role ensures robust GxP compliance, supports EU MDR obligations, and drives audit readiness while enabling efficient, scalable operations.

Key responsibilities

• Lead site compliance activities across Quality Systems and Complaints processes to align with cGMP, Health Authority requirements, and ISO standards.
• Identify, assess, and escalate compliance and regulatory risks affecting product conformity, patient safety, or regulatory standing.
• Drive audit readiness and execution, prepare for internal and Health Authority inspections, and manage remediation plans.
• Act as primary site interface during regulatory inspections and critical audits.
• Implement and sustain quality strategies, governance, metrics, and escalation mechanisms.
• Identify and execute continuous‑improvement opportunities to increase efficiency and reduce compliance risk.
• Provide compliance leadership, guidance on policies, procedures, and regulatory expectations, and ensure effective training.
• Partner with cross‑functional leaders to assess risk, support investigations, and integrate quality considerations into decisions.
• Lead, develop, and mentor teams, ensuring adherence to GxP expectations, SOP execution, documentation, and training.
• Serve as Deputy PRRC for ITC, supporting EU MDR compliance and overseeing quality system effectiveness.

Required profile

• Bachelor’s degree or equivalent.
• Extensive experience in quality assurance and regulatory compliance within a GxP environment.

Required skills

• cGMP
• GxP
• ISO standards
• EU MDR