Sr. Manager, Quality Control Labs

Alcon Research•Houston, TX

5d•Onsite

About The Position

The Sr. Manager, Quality Control Labs leads laboratory operations at Alcon’s manufacturing facility in Houston, Texas. The role ensures compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Documentation Practice (GDP), and other GxP requirements. It oversees personnel qualifications, equipment validation, investigations, corrective and preventive actions (CAPA), health, safety and environment (HSE), budget, and Quality Assurance (QA) functions. The position leads multiple Quality Control teams and oversees Microbiology, Analytical Science and Technology (AS&T), Incoming Inspection, and Calibration / Metrology. It provides strategic direction, allocates resources, approves projects, and establishes performance metrics to support product and raw-material compliance, customer deadlines, site initiatives, and budgetary requirements. The role also develops and improves QA programs and processes, supports audits and inspections, and reviews and approves quality documents, change controls, and deviation management records. The role is onsite in Houston, Texas, with standard hours Monday through Friday, 8:00 AM to 5:00 PM CST. Travel may be required up to 10%.

Requirements

Bachelor’s degree or equivalent years of directly related experience; alternatively, high school education plus 15 years, an associate degree plus 11 years, a master’s degree plus 4 years, or a PhD plus 3 years.
Fluency in reading, writing, understanding, and communicating in English.
At least 7 years of relevant experience.
At least 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 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, maintain accurate documentation, and promote required training and rigorous quality control.
Develop strategies and direct the Quality Control team to meet customer deadlines, report metrics and KPIs, and complete CAPAs and action items on time.
Develop and improve QA programs, policies, processes, procedures, and controls to ensure 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.
Plan and execute project activities in alignment with site initiatives and budgetary requirements.
Review and approve quality documents, Quality Control-related change controls, and deviation management records.
Supervise OOS, OEE, and OOT investigations and implement CAPAs.
Oversee HSE, budget, personnel qualifications, and equipment validation.