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Lonza

Global life sciences contract manufacturer

Quality Assurance Supervisor - Night Shift

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours
Full-timePearland, TX, USA

About the Job

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

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

Desired Qualifications

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

About the Company

Lonza

Global life sciences contract manufacturer

Lonza is a global provider of development and manufacturing services for the pharmaceutical, biotechnology, and nutrition sectors. It supports clients from early development through to commercial production, offering integrated processes such as process development, GMP manufacturing, formulation, fill-finish, and quality assurance to bring medicines and nutrition products to market. Lonza’s model is built on end-to-end CDMO capabilities, enabling companies to move from concept to scalable, compliant production with reliable supply chains. What sets Lonza apart is its long history and global footprint, combining decades of experience across chemistry, biology, and nutrition with a broad, end-to-end service network that supports projects from discovery to commercialization. The company aims to be a trusted, long-term partner in life sciences by helping customers efficiently develop and manufacture their products at scale while maintaining strict regulatory and quality standards.

Company size
10,001+
Company stage
IPO
Headquarters
Basel, Switzerland
Founded
1897

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