Site Quality Director: GMP & Compliance Leader

Lonza Group Ltd.; Houston (TX); On-site; USD 180,000 - 280,000; Full time

Job summary

Lonza Group Ltd. is seeking a Senior Director, Head of Quality to lead the Site Quality organization and drive a robust quality strategy. The role focuses on GMP compliance, regulatory readiness, and continuous improvement across Operations, R&T and partner relations.

The successful candidate will provide strategic leadership, manage audits, and ensure alignment with customer needs while delivering productivity and budgetary goals in a fast-paced environment.

Qualifications

• Leadership experience in quality assurance and quality control within GMP.
• Deep expertise in GxP, ISO standards, FDA regulations and quality compliance frameworks.
• Proven change leader who drives adoption of new ways of working and aligns teams to transformation.
• Ability to translate corporate strategy into critical success factors and executable plans.
• Demonstrated senior leadership with budgeting and remediation experience.

Responsibilities

• The Quality Site Head is a prominent member of the site leadership team and will be onsite mostly to support key responsibilities.
• The Quality Head for the site, is the leading source of Quality and GMP related expertise within the site and is responsible for providing the strategic leadership and management for the Site` Quality organization
• Provide leadership to the Site Quality organization to ensure that teamwork, high morale and innovation are fundamental components of a team
• Develop and execute the Quality strategy commensurate with the overall plan for the company
• Ensure alignment with customer needs and linkage with the overall Quality and business strategies
• Implement continuous improvement initiatives to drive Quality programs and ensure maximum productivity.
• Ensure systems meet the needs of all internal and external constituencies with an emphasis on process, quality, productivity, budget control, and profitability
• Develop, implement and monitor Quality programs, policies and procedures to ensure compliance with GMP standards, corporate policies, FDA, EMA and other regulatory body regulations and guidelines
• Serve as the point person with industry partners regarding product quality matters, customer satisfaction levels and regulatory authority interaction.
• Oversee all partner and regulatory authority audits and inspections and corrective action programs
• Evaluate all current Quality systems and processes and recommend and implement appropriate enhancements to ensure the achievement of Lonza's long-term objectives
• Create active training and development plans for Quality staff with the objective of driving the overall competence and professionalism of the Quality functions
• Establish and maintain a positive working relationship with customers, the FDA and other regulatory authorities.
• Represent the Lonza on quality and cGMP compliance issues that are specific to the site
• Serve as the company Quality expert, providing solid, well-informed, actionable Quality support to Operations, R&T, and other functions as requested

Skills

Leadership

GxP

ISO & FDA

Quality Assurance

Quality Control

Budgeting

Strategic QA

Project Management

Stakeholder Mgmt

Communication

Job description

Lonza Group Ltd. is seeking a Senior Director, Head of Quality to lead the Site Quality organization and drive a robust quality strategy. The role focuses on GMP compliance, regulatory readiness, and continuous improvement across Operations, R&T and partner relations.

The successful candidate will provide strategic leadership, manage audits, and ensure alignment with customer needs while delivering productivity and budgetary goals in a fast-paced environment.