Quality Site Head

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

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of. The Senior Director, Head of Quality at our site leads a dedicated team focused on innovation and excellence. Seeking an ambitious leader to develop quality strategies.

Key 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

Key requirements

• Commercial Manufacturing demonstrated experience.
• Confirmed leadership experience in quality assurance and quality control within a GMP environment.
• 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 implementation plans.
• Demonstrated senior leader with sustained 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.
• Excellent problem-solving skills with a results-oriented, pragmatic, and urgency-driven mindset.
• 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.

Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.