Night Shift QA Supervisor – GMP Biopharma

Lonza Group Ltd.; Houston (TX); On-site; USD 90,000 - 115,000; Full time

Benefits offered by this job

Performance bonus

Shift differential 15%

Medical, dental and vision insurance

401(k) matching plan

Life insurance

Short-term and long-term disability

Employee assistance programs

Paid time off

Job summary

Lonza Houston Inc. is seeking a Quality Assurance Supervisor for the night shift to oversee QA activities on the manufacturing floor and ensure regulatory compliance.

The role includes supervising QA staff, reviewing batch records and deviations, and supporting audits and inspections. You will collaborate with Manufacturing, MSAT, Facilities and Quality Systems to maintain product integrity and drive continual improvement.

Qualifications

• Minimum 5–10 years in QA within GMP environments.
• Bachelor’s degree in a scientific discipline is required.
• Experience leading or supervising teams and evaluating performance.
• Strong understanding of cGMP, regulatory requirements and quality systems.
• Experience with deviations, investigations, CAPAs and change control processes.
• Ability to work in a cleanroom environment and gowning.
• Proven ability to manage multiple priorities and lead cross-functional teams.
• Strong written and verbal communication skills, with stakeholder engagement.

Responsibilities

• Supervise and lead a team of QA personnel, including coaching and evaluations.
• Provide QA on-the-floor support for manufacturing operations and ensure cGMP compliance.
• Review and approve GMP documentation including batch records, deviations, CAPAs, and SOPs.
• Support and lead investigations, 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.
• Perform QA walkthroughs and oversee production activities to identify quality issues.
• Ensure training compliance and development of QA staff in line with requirements.
• Support gowning requirements and cleanroom activities as needed.

Skills

Leadership experience

Quality Assurance

cGMP knowledge

Regulatory knowledge

Strong communication

Stakeholder engagement

Manage multiple priorities

Document control systems

Education

Bachelor’s degree in life sciences or engineering

Tools

Document control systems

Job description

Lonza Houston Inc. is seeking a Quality Assurance Supervisor for the night shift to oversee QA activities on the manufacturing floor and ensure regulatory compliance.

The role includes supervising QA staff, reviewing batch records and deviations, and supporting audits and inspections. You will collaborate with Manufacturing, MSAT, Facilities and Quality Systems to maintain product integrity and drive continual improvement.