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Lonza

Global life sciences contract manufacturer

Quality Site Head

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours
Full-timeHouston, TX, USANo salary listed

About the Job

Requirements

  • Demonstrated experience in commercial manufacturing.
  • Confirmed leadership experience in quality assurance and quality control within a Good Manufacturing Practice environment.
  • Deep expertise in GxP, ISO standards, FDA regulations, and quality compliance frameworks.
  • Proven change leadership, including driving adoption of new ways of working and aligning teams to transformation.
  • Ability to translate corporate strategy into critical success factors and executable implementation plans.
  • Sustained senior-leader performance, including compliance remediation, turnaround experience, and budgeting.
  • Strong track record in developing and executing strategic quality initiatives.
  • Experience leading, developing, and influencing teams within a complex, matrixed organization.
  • Ability to manage multiple projects simultaneously while meeting aggressive deadlines.
  • Strong communication, negotiation, facilitation, mentoring, and stakeholder-management skills.
  • Proven ability to promote a culture of empowerment, accountability, rigor, and effective issue escalation and reporting.

Responsibilities

  • Provide strategic leadership and management for the site's Quality organization and serve as its leading source of Quality and Good Manufacturing Practice expertise.
  • Lead the Site Quality organization, fostering teamwork, high morale, and innovation.
  • Develop and execute the Quality strategy in alignment with the company's overall plan, customer needs, and business strategies.
  • Implement continuous-improvement initiatives and Quality programs to maximize productivity; ensure systems address process, quality, productivity, budget-control, and profitability needs.
  • Develop, implement, and monitor Quality programs, policies, and procedures to ensure compliance with Good Manufacturing Practice standards, corporate policies, FDA and EMA regulations, and other regulatory guidance.
  • Serve as the point person with industry partners on product quality, customer satisfaction, and regulatory-authority interactions; oversee partner and regulatory audits and inspections and corrective-action programs.
  • Evaluate Quality systems and processes and implement enhancements supporting the company's long-term objectives.
  • Create training and development plans for Quality staff to build competence and professionalism.
  • Maintain positive working relationships with customers, the FDA, and other regulatory authorities; represent the company on site-specific quality and cGMP compliance issues.
  • Provide actionable Quality support to Operations, R&T, and other functions as requested.

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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