Sr. Manager, Quality Control Labs

Alcon•Houston, TX

6d•Onsite

About The Position

The Sr. Manager, Quality Control Labs is part of Alcon's Quality & Regulatory Affairs function and leads laboratory operations at the Houston, Texas manufacturing facility. The role ensures compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Documentation Practice (GDP), and applicable GxP requirements. It also manages personnel qualifications and equipment validation and oversees Health, Safety, and Environment (HSE), budget, and Quality Assurance (QA) functions. The position leads multiple quality control teams covering Microbiology, Analytical Science and Technology (AS&T), Incoming Inspection, and Calibration / Metrology. It provides strategic direction, approves projects, allocates resources, and develops programs, policies, processes, procedures, controls, and performance metrics to ensure product quality, regulatory compliance, customer satisfaction, and timely delivery. The manager also oversees investigations and corrective actions, supports audits and inspections, and reviews quality documentation and records. The position is onsite, Monday through Friday, 8:00 AM to 5:00 PM CST, with travel of up to 10%.

Requirements

Bachelor’s degree or equivalent years of directly related experience; alternatively, high school plus 15 years, an associate degree plus 11 years, a master’s degree plus 4 years, or a PhD plus 3 years.
Fluent ability to read, write, understand, and communicate in English.
7 years of relevant experience.
5 years of demonstrated leadership.

Nice To Haves

Degree in Science or Engineering.
Experience in the medical device or pharmaceutical industries.

Responsibilities

Lead multiple quality control laboratory teams to ensure products and raw materials comply 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 and SOPs and maintain accurate documentation.
Promote rigorous quality control and ensure required training is completed.
Encourage associates to meet job requirements and contribute to organizational compliance.
Develop strategies and provide direction to the Quality Control team to meet customer deadlines, report metrics/KPIs, and complete CAPAs and action items on time.
Develop and improve QA programs, policies, processes, procedures, and controls so product performance and quality meet established standards and agency guidelines.
Support internal and external audit inspections.
Establish metrics to monitor, improve, and sustain Quality Control team performance.
Allocate resources to lead, plan, and execute project activities aligned with site initiatives and budget requirements.
Review and approve quality documents, Quality Control-related change controls, and deviation management records.
Supervise OOS, OEE, and OOT investigations and implement CAPAs.