Quality Assurance Supervisor - Night Shift

Lonza • Houston, TX

2d • Onsite

About The Position

The Quality Assurance Supervisor - Night Shift will oversee quality assurance activities during the night shift (5:00 PM - 2:00 AM, Monday - Friday) at Lonza Houston Inc., ensuring compliance with all regulatory requirements and internal quality standards for the manufacturing of biopharmaceutical products. This role involves direct supervision of QA personnel and active participation in quality system management to maintain product integrity and safety.

Requirements

• Experience from 5 to 10 years in Quality Assurance within GMP-regulated environments.
• Minimum of Bachelor’s degree required in a scientific discipline (life sciences or engineering preferred).
• Previous leadership or supervisory experience, including managing teams and performance evaluations.
• Strong understanding of cGMP principles, regulatory requirements, and quality systems.
• Experience with deviations, investigations, CAPAs, and change control processes.
• Ability to work in a cleanroom environment and perform gowning requirements.
• Demonstrated ability to manage multiple priorities and lead cross-functional teams.
• Strong communication skills, including technical writing and stakeholder engagement.

Nice To Haves

• Experience with document control systems preferred.
• Knowledge of biologics, viral vectors, or cell and gene therapy manufacturing preferred.

Responsibilities

• Supervise and lead a team of QA personnel, including coaching, mentoring, and conducting performance evaluations.
• Provide QA on-the-floor (QAOTF) support for manufacturing operations and ensure compliance with cGMP requirements.
• Review and approve GMP documentation including batch records, deviations, change controls, CAPAs, and SOPs.
• Support and lead investigations, including deviations, OOS events, and corrective actions.
• Act as QA representative during internal and external audits and regulatory inspections.
• Collaborate cross-functionally with Manufacturing, MSAT, Facilities, and Quality Systems teams.
• Perform QA walkthroughs and provide real-time oversight of production activities to identify and resolve quality issues.
• Ensure training compliance and development of QA staff in alignment with site and regulatory requirements.
• Support gowning requirements (Level 3 / Grade B) and cleanroom activities as needed.

Benefits

• Performance-related bonus.
• Shift differential (15%).
• Medical, dental and vision insurance.
• 401(k) matching plan.
• Life insurance, as well as short-term and long-term disability insurance.
• Employee assistance programs.
• Paid time off (PTO).

What This Job Offers

• Job Type: Full-time
• Career Level: Manager