Alcon

Medical Device

Sr.Manager,QualityAssuranceCompliance

$0–0k Irvine, California, United States FULL TIME
The Brief

“Sr. Manager, Quality Assurance Compliance at Alcon. Skills: Quality Assurance Compliance, GxP compliance, Regulatory Affairs, Audit readiness. Lead and oversee site compliance activities. Proactively identify, assess, and escalate compliance risks”

What You'll Achieve.

Strengthen site's quality systems; Strengthen site's compliance posture; Strengthen site's audit readiness; Ensure robust GxP compliance; Enable efficient, scalable operations; Support EU MDR compliance obligations; Ensure alignment with current Good Manufacturing Practices; Ensure alignment with Health Authority requirements; Ensure alignment with ISO standards; Ensure product conformity; Ensure patient safety; Ensure regulatory standing; Sustainable closure of audit findings; Ensure processes, metrics, and escalation mechanisms support compliance; Ensure processes, metrics, and escalation mechanisms support operational effectiveness; Increase process efficiency; Reduce compliance risk; Simplify quality workflows; Ensure effective training and adoption; Ensure quality considerations are integrated into operational decisions; Impact quality operations; Impact site performance; Proper execution of SOPs; Completion of required training; Oversight of quality system effectiveness; Oversight of compliance-related activities; Escalation of regulatory risks

Industry & Context.

Medical Device
Problems you'll solve

Risk assessment; Support investigations

What They're Looking For.

Must Have

Bachelor's Degree or Equivalent years of directly related experience, Ability to fluently read, write, understand, and communicate in English, 7 Years of Relevant Experience

Nice to Have

5 Years of Demonstrated Leadership, Experience in Quality/Manufacturing/Operations/Engineering in Medical Device, Experience working in current Quality Management Systems (MES, SAP, Trackwise, Teamcenter)

What You'll Do.

Lead and oversee site compliance activities

and escalate compliance risks

Drive audit readiness and execution

Act as primary site interface during inspections

Implement and sustain quality strategies

Identify and execute continuous improvement opportunities

Provide compliance leadership and guidance

Partner with cross-functional leaders

Ensure adherence to GxP expectations

Serve as Deputy PRRC for ITC

How You'll Work.

Team & Collaboration

Partner with cross-functional leaders; Collaborate with teammates

Communication Scope

Communicate in English; Communication

Process & Methodology

Project management

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