This role is part of Alcon's
Quality & Regulatory Affairs function, a team that ensures our products are in compliance with global, local, and internal regulations and meet the strictest standards of quality as we help people see brilliantly.
The
Sr. Manager, Quality Control Labs is primarily responsible for leading laboratory operations, ensuring compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Documentation Practice (GDP), and managing personnel qualifications and equipment validation. You will supervise Out of Specification (OOS), Overall Equipment Effectiveness (OEE), and Out of Trend (OOT) investigations, implement Corrective and Preventive Actions (CAPA), and oversee Health, Safety, and Environment (HSE), budget, and Quality Assurance (QA) functions at our
Manufacturing Facility in Houston, TX. Specifics Include:
- Lead multiple teams in quality control labs to ensure product and raw material compliance with specifications and standards.
- Guide and supervise team activities, make key decisions, approve projects, and allocate resources.
- Oversee Microbiology, Analytical Science and Technology (AS&T), Incoming Inspection, and Calibration / Metrology for quality and customer compliance.
- Ensure adherence to GxP regulations, SOPs, and maintain accurate documentation.
- Promote rigorous quality control and complete all required training.
- Encourage associates to meet job requirements and contribute to organizational compliance.
- Develop strategies and provide directions to the Quality Control team to ensure they are meeting customer deadlines, metrics/KPI reporting, timely completion of CAPAs/Action items.
- Develop and improve QA programs, policies, processes, procedures, and controls to ensure that product performance and quality conform to established standards and agency guidelines.
- Provide support for internal and external audit inspections.
- Provide strategic leadership to the Quality Control team to establish metrics to monitor, improve, and sustain performance.
- Allocate resources to lead, plan, and execute project activities in alignment with site initiatives and budgetary requirements.
- Review and approval of quality documents, change controls related to Quality Control, and deviation management records.
- All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training.
- Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations.
WHAT YOU'LL BRING TO ALCON:- 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
- 5 years of demonstrated leadership
- Work Hours: Monday - Friday, 8:00 AM - 5:00 PM CST
- Location: Onsite
- Travel Requirements: Up to 10%
- Relocation Assistance: No
- Sponsorship Available: NO
PREFFERED:- Degree in Science or Engineering
- Medical device or pharmaceutical industries
HOW YOU CAN THRIVE AT ALCON:- Collaborate with teammates to share standard processes and learnings as work evolves!
- Join Alcon's mission to provide top-tier, innovative products and solutions to enhance sight & enhance lives.
- Grow your career in a highly collaborative and diverse environment.
- Alcon provides robust benefits package including health, life, retirement, flexible time off for salaried associates, paid time off for hourly associates and much more!
Alcon CareersSee your impact at alcon.com/careers
ATTENTION: Current Alcon Employee/Contingent WorkerIf you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.
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