
Posted a day ago
Sr. Manager, Quality Control Labs
Alcon
Requirements
Bachelor's Degree or equivalent experience, 7 years of relevant experience, 5 years of leadership experience, Knowledge of cGMP, cGLP, FDA, and global regulatory requirements, Experience with OOS, OOT, and deviations
Skills
GMPGLPLIMSQuality Management SystemSix Sigma
About the role
Responsibilities
- Lead and oversee QC laboratory operations to ensure accurate, reliable, and compliant analytical results for product release and lifecycle management.
- Ensure laboratory compliance with cGMP, cGLP, FDA, and global regulatory requirements.
- Own and maintain QC-related elements of the Quality Management System (QMS).
- Lead regulatory inspections, audits, and responses (FDA, ISO, and internal audits).
- Oversee investigations for OOS, OOT, deviations, and non-conformances, ensuring effective root cause analysis and CAPA implementation.
- Manage testing schedules, capacity planning, and laboratory workflows to meet production demands.
- Lead, coach, and develop QC managers, supervisors, and analysts while driving a high-performance, quality-focused culture.
- Define and track QC metrics such as right-first-time rates, cycle times, and backlogs.
- Drive continuous improvement initiatives using Lean or Six Sigma methodologies.
- Manage QC laboratory budgets, operating plans, and resource allocation.
Requirements
- Bachelor's Degree or equivalent years of directly related experience.
- 7 years of relevant experience in a laboratory or quality control environment.
- 5 years of demonstrated leadership experience.
- Strong knowledge of cGMP, cGLP, FDA, and global regulatory requirements.
- Proven experience managing OOS, OOT, and deviations.
- Ability to fluently read, write, understand, and communicate in English.
About the Company
Alcon is a global leader in eye care, dedicated to helping people see brilliantly. We develop and manufacture innovative devices and solutions across the full life cycle of eye care needs, including surgical equipment and consumer products. With more than 25,000 associates worldwide, we foster an inclusive culture where we innovate fearlessly to impact global eye health.
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Alcon · Fort Worth
