Sr. Manager, Quality Control Labs

U341 Alcon Research, LLC. Company; Houston (TX); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Flexible PTO

Job summary

Alcon is seeking a Sr. Manager, Quality Control Labs in Houston to lead laboratory operations, ensure GMP/GLP/GDP compliance, and oversee all QA functions at the site.

You will manage OOS, OEE, and OOT investigations, CAPA programs, and audit support while directing personnel qualifications and equipment validation. The role requires a bachelor’s degree in science or engineering, 7+ years of relevant experience, and 5+ years of leadership.

Qualifications

• Bachelor’s degree required; science/engineering field preferred.
• Strong leadership with 5+ years in QA/QC roles.
• Demonstrated knowledge of GMP/GLP/GDP and regulatory standards.

Responsibilities

• Lead multiple QC labs to ensure product and material compliance.
• Oversee CAPA, OOS/OEE/OOT investigations and audits.
• Manage budgets, resources and personnel qualifications.
• Ensure SOPs, GDP and regulatory guidelines are followed across the site.

Skills

Leadership

Regulatory compliance

GMP/GLP/GDP knowledge

SOP adherence

Decision making

Education

Bachelor’s degree in Science or Engineering

Job description

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us?

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 IS AN EQUAL OPPORTUNITY EMPLOYER AND PARTICIPATES IN E-VERIFY

Alcon takes pride in maintaining an inclusive environment that values different perspectives and our policies are non-discriminatory in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to [e-mail] and let us know the nature of your request and your contact information.

At Alcon, we are committed to helping people see better.

We believe patients should have access to quality eye care regardless of their economic circumstances; however, barriers to good eye health exist for patients in both developed and emerging markets.

Alcon develops and manufactures innovative devices to serve the full life cycle of eye care needs.

Its surgical group is one of the largest makers of equipment used for cataract removal and laser vision correction.

Its consumer products include the well-known Opti‑Free line of contact lens solutions and related products.

Alcon, which was founded in 1945, sells its products in 180 countries worldwide.