Lead and oversee site compliance activities across Quality Systems and Complaints processes to ensure alignment with current Good Manufacturing Practices (cGMP), Health Authority requirements, and ISO standards.
Proactively identify, assess, and escalate compliance and regulatory risks that may impact product conformity, patient safety, or regulatory standing.
Drive audit readiness and execution , including preparation for internal and Health Authority inspections; lead response development, remediation plans, and sustainable closure of audit findings.
Act as a primary site interface during regulatory inspections and critical audits , ensuring alignment, consistency, and accurate representation of site practices.
Implement and sustain quality strategies and governance , ensuring processes, metrics, and escalation mechanisms support both compliance and operational effectiveness.
Identify and execute continuous improvement opportunities to increase process efficiency, reduce compliance risk, and simplify quality workflows without compromising standards.
Provide compliance leadership and guidance on policies, procedures, and regulatory expectations; ensure effective training and adoption across the organization.
Partner with cross‑functional leaders to proactively assess risk, support investigations, and ensure quality considerations are integrated into operational decisions.
Lead, develop, and mentor teams , making informed decisions that impact quality operations and site performance through strong leadership, project management, and communication.
Ensure adherence to GxP expectations , including proper execution of SOPs, accurate and complete documentation, and completion of required training.
Serve as Deputy PRRC for ITC , supporting PRRC responsibilities under EU MDR, including oversight of quality system effectiveness, compliance-related activities, and escalation of regulatory risks as appropriate.
Key Requirements/Minimum Qualifications:
Bachelor's Degree or Equivalent years of directly related experience (or high school +15 yrs.; Assoc.+11 yrs.; M.S.+4 yrs.; PhD+3 yrs.)
The ability to fluently read, write, understand, and communicate in English
7 Years of Relevant Experience
Relocation Assistance: Not Available
Sponsorship Available: Not Available
Preferred requirements:
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)
How to Thrive at Alcon:
Join Alcon's mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
Collaborate with teammates to share standard processes and findings as work evolves!
See your career like never before with focused growth and development opportunities!
Alcon provides robust benefits package including health, life, retirement, flexible time off for exempt associates, and much more!
Alcon Careers
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Benefits
The salary range posted represents the anticipaHealth insuranceFlexible schedule
Additional Information
This role is part of Alcon's Quality & Regulatory Affairs organization, which ensures our products comply with global, regional, and internal regulatory requirements, and consistently meet the highest standards of quality as we help people see brilliantly.
The Senior Manager, Quality Assurance Compliance serves as a key Quality leader at the Irvine Technology Center (ITC), responsible for strengthening the site's quality systems, compliance posture, and audit readiness. This role partners closely with Manufacturing, Engineering, Supply Chain, and Regulatory functions to ensure robust GxP compliance while enabling efficient, scalable operations. The role also serves as the site's Deputy Person Responsible for Regulatory Compliance (Deputy PRRC), supporting EU MDR compliance obligations and acting on behalf of the PRRC as delegated and permitted. This is an onsite position based out of our Irvine-Alton Parkway location.
Alcon · Irvine, CA