Quality Site Head Slough

Lonza; Slough; Hybrid; Confidential; Full time

Job summary

Lonza's Slough site seeks a Quality Site Head to lead the QA/QC strategy, establish the local QMS and ensure timely product release in line with US FDA and EU GMP.

You will develop staff, manage Quality operations and validation, drive continuous improvement, and act as the main interface with MHRA/FDA during inspections.

As a Site Leadership Team member, you will align manufacturing with quality strategy and build regulatory-ready processes for ongoing compliance.

Qualifications

• PhD Degree in a Life science, Engineering or Quality Management or related science discipline.
• ACCA, GPHR, CIPS, PgMP qualified person is desirable, but not necessary
• Experience within Quality Operations or Quality Systems GMP environment
• Experience within Pharma or Biopharmaceutical manufacturing.

Responsibilities

• Lead QA/QC strategy and site QMS to meet regulatory requirements.
• Oversee QC activities, including biochemistry, microbiology, environmental monitoring, raw materials, stability, method validation, method transfer, instrument and software qualification, data integrity, sample management and QC document management.
• Ensure timely product release to customers in line with regulations and Lonza Global Quality requirements.
• Train, supervise and develop staff; maintain cGMP compliance and support site projects with Operations and site leadership.
• Act as a member of the Slough Site Leadership Team to ensure compliance and value delivery.

Skills

Leadership

Regulatory knowledge

Quality management

GMP experience

Education

PhD in Life science / Engineering / Quality Management

Tools

ACCA

GPHR

CIPS

PgMP

Job description

Today, Lonza is a global leader in life sciences operating across five 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.

We are looking for a Quality Site Head, Slough.

Role Purpose:

• Plans, leads and coordinates a Quality Assurance / Quality Control strategy that positively impacts the quality and financial goals of the company, in establishing and maintaining the site Quality Management System in compliance with applicable law and regulations and Lonza Global Quality requirements.
• Champions continuous improvement efforts to establish an effective Quality Management System. Overseas all Quality control activities, including but not limited to biochemistry, microbiology, environmental monitoring, raw materials, stability, method validation, method transfer, instrument and software qualification, data integrity, sample management and QC document management.
• Assures timely product release to customers according to regulations and Lonza Global Quality requirements.
• Trains, supervises and develops staff, assures that the site remains under control with respect to cGMP, determine quality management strategy and support the Site Projects incollaborating with Operations and site executive management.
• As member of the Slough Site Leadership Team, actively participates and contributes to the overall compliance, and value delivery to Lonza and our customers.

Develop and lead the overall Quality (QA & QC) strategy for the site. Partner with Senior Site Director and Senior Leadership Team to ensure alignment of Manufacturing and support functions in executing the strategy. Act as the Lead SME for significant quality / GMP issues at the site.

Develop, direct and maintain the local Quality System at Slough and contribute to the development and maintenance of global quality systems in line with Lonza Corporate requirements and standards and current regulatory requirements, meeting US FDA and European requirements and others as needed. Ensure escalation of non-compliance or ineffective Quality System deployment at site.

Provide leadership to the Quality Control organization. Ensure quality and delivery of QC objectives and responsibilities to Lonza and customers. Develop and implement continuous improvement actions against the key performance indicators and targets identified for the area and the Slough site.

Build and Maintain expertise in QA, QC & Validation teams; ensure execution and expertise is effective in supporting site operations through ongoing development of staff. Ensure the QA team maintains appropriate independence to ensure that there is no conflict of interest between regulatory requirements and day to day operational priorities.

Set up and control the budget for the Quality Unit and adequate resources.

Accomplish corporate business objectives by improving site quality systems and enforcing regulatory compliance.

Act as the primary interface with MHRA, FDA and other regulatory agencies during regulatory inspections. Maintain strong working relationships with regulatory agencies. Ensure regulatory commitments are met on time and sustainability measures are in place. Ensure site is ‘ inspection ready’ at all times.

Partners with key customers on quality strategy and execution of QA/QC responsibilities. Serve on joint Lonza-customer teams.

Key Stakeholders:

Global Head of Quality.

Cross- functional units.

Thorough understanding of regulatory requirements for biologics manufacturing; interpretation and application of the US and EU GMPs. Familiarity with biologics manufacturing processes and technical issues is strongly desired.

Strong leadership skills; must be capable of managing, motivating and developing the QA/QC team, both by personal example and by credibility and influence. Strong interpersonal and communication skills needed to implement a robust quality system throughout all functions at the site.

Pragmatism, optimism, teamwork and knowledge-sharing are all key qualities for success as the Site Head of Quality. This role is required to inspire and complete excellence in performance from the leadership team., QA/QC teams and the broader Slough organization through visible energy, enthusiasm and credibility.

Qualifications & Experience

PhD Degree in a Life science, Engineering or Quality Management or related science discipline

ACCA, GPHR, CIPS, PgMP qualified person is desirable, but not necessary

Experience within Quality Operations or Quality Systems GMP environment

Experience within Pharma or Biopharmaceutical manufacturing.

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.